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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Ajinomoto Company, Inc.

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2'3'-DIDEOXYINOSINE

6-MERCAPTOPURINE

A-4166

A-84538.0 (RITONAVIR)

ACYCLOVIR

ADENOSINE

AMINO ACID MIXTURE BAX-D

AMINO ACID PRODUCTS

AMINO ACIDS

AMPHOTERICIN B

AT-1015 A 5-HT2A ANTAGONIST

Acetylcysteine

Alanine SA

Aspartic Acid

BALSALAZIDE DISODIUM

CILOSTAZOL

CURDLAN SULFATE SODIUM INTRAVENOUS

Cilnidipine bulk powder

DIPYRIDAMOLE

Didanosine bulk powder

File stick bulk powder

GALANTAMINE HBR

GALANTAMINE HYDROBROMIDE

GLYCYL-L-GLUTAMINE HYDRATE

Histidine

Histidine SA

INTRAVENOUS LENTINAN

IRBESARTAN CRUDE

Japanese Pharmacopoeia L- cysteine ​​hydrochloride hydrate \"production-only\"

Japanese Pharmacopoeia L- valine (production only)

L- cysteine ​​hydrochloride (monohydrate) (day professional)

L-ALANINE

L-ALANYL-GLUTAMINE

L-ARGININE

L-ARGININE MONOHYDROCHLORIDE

L-ASPARTIC ACID

L-CYSTEINE HYDROCHLORIDE MONOHYDRATE

L-GLUTAMIC ACID

L-GLUTAMINE

L-HISTIDINE

L-HISTIDINE MONOHYDROCHLORIDE MONOHYDRATE

L-ISOLEUCINE

L-LEUCINE

L-LYSINE ACETATE

L-LYSINE MONOHYDROCHLORIDE

L-PHENYLALANINE

L-PROLINE

L-SERINE

L-SERINE (PROCESS II)

L-THREONINE

L-TRYPTOPHAN

L-TYROSINE

L-VALINE

LEVODOPA

Lysine Hydrochloride

Lysine Hydrochloride SA

MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN YOKKAICHI, MIE PREFECTURE, JAPAN

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF CRYSTALLINE AMINO ACIDS IN RALEIGH, NORTH CAROLINA.

MICONAZOLE NITRATE

Mesalazine

N-ACETYL-D-GLUCOSAMINE

Nafamostat mesylate -A

Outsiders regulations L- cystine (production only)

PRAZOSIN HYDROCHLORIDE

Quetiapine fumarate

Threonine L-Threonine II

Vidarabine \"Ajinomoto\"

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Status - Active

Status - Inactive

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VALID

WITHDRAWN BY HOLDER

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217MF10297

217MF10298

217MF10300

217MF10553

217MF10807

217MF10830

218MF10525

218MF10637

218MF10641

218MF10906

218MF11012

220MF10015

220MF10016

220MF10073

220MF10234

220MF10239

221MF10284

223MF10042

223MF10057

224MF10004

224MF10005

224MF10006

224MF10007

224MF10008

224MF10059

226MF10002

226MF10025

226MF10084

226MF10085

227MF10115

227MF10116

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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
2'3'-DIDEOXYINOSINE
Issue/Submission Date
1988-09-30
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
2'3'-DIDEOXYINOSINE
Issue/Submission Date
1988-09-30
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
6-MERCAPTOPURINE
Issue/Submission Date
1991-09-23
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
6-MERCAPTOPURINE
Issue/Submission Date
1991-09-23
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
A-4166
Issue/Submission Date
1994-10-24
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
A-4166
Issue/Submission Date
1994-10-24
Supporting Info
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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Acetylcysteine
Issue/Submission Date
2009-04-23
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Japanese Pharmacopoeia-acetylcystei...
Issue/Submission Date
2012-01-18
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
VALID
 
Filing Details
Acetylcysteine
Japanese Pharmacopoeia-acetylcystei...
Issue/Submission Date
2009-04-23
2012-01-18
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
ACYCLOVIR
Issue/Submission Date
1993-03-02
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
 
Filing Details
ACYCLOVIR
Issue/Submission Date
1993-03-02
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
ADENOSINE
Issue/Submission Date
2004-08-16
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
ADENOSINE
Issue/Submission Date
2004-08-16
Supporting Info
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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Alanine SA
Issue/Submission Date
2015-08-26
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
VALID
 
Filing Details
Alanine SA
Issue/Submission Date
2015-08-26
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
AMINO ACIDS
Issue/Submission Date
1982-03-17
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
AMINO ACIDS
Issue/Submission Date
1982-03-17
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
AMINO ACID MIXTURE BAX-D
Issue/Submission Date
2004-05-24
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
AMINO ACID MIXTURE BAX-D
Issue/Submission Date
2004-05-24
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
AMINO ACID PRODUCTS
Issue/Submission Date
1967-08-15
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Isoleucine Limeira Amino Acid site
Issue/Submission Date
2014-12-16
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Filing Details
AMINO ACID PRODUCTS
Isoleucine Limeira Amino Acid site
Issue/Submission Date
1967-08-15
2014-12-16
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
AMPHOTERICIN B
Issue/Submission Date
1998-04-30
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
AMPHOTERICIN B
Issue/Submission Date
1998-04-30
Supporting Info
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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Aspartic Acid
Issue/Submission Date
2018-02-01
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
VALID
 
Filing Details
Aspartic Acid
Issue/Submission Date
2018-02-01
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
BALSALAZIDE DISODIUM
Issue/Submission Date
1996-12-20
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
BALSALAZIDE DISODIUM
Issue/Submission Date
1996-12-20
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
BALSALAZIDE DISODIUM
Issue/Submission Date
2003-01-02
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
BALSALAZIDE DISODIUM
Issue/Submission Date
2003-01-02
Supporting Info
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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Cilnidipine bulk powder at Chuo-ku,...
Issue/Submission Date
2005-06-30
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
 
Filing Details
Cilnidipine bulk powder at Chuo-ku,...
Issue/Submission Date
2005-06-30
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
CILOSTAZOL
Issue/Submission Date
2004-05-12
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
CILOSTAZOL
Issue/Submission Date
2004-05-12
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Unpaid
DMF Review - Complete
Filing Details
L-CYSTEINE HYDROCHLORIDE MONOHYDRAT...
Issue/Submission Date
2008-02-26
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Cysteine Hydrochloride Monohydrate
Issue/Submission Date
2014-08-05
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Japanese Pharmacopoeia L- cysteine ...
Issue/Submission Date
2008-01-09
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Unpaid
DMF Review - Complete
VALID
 
Filing Details
L-CYSTEINE HYDROCHLORIDE MONOHYDRAT...
Cysteine Hydrochloride Monohydrate
Japanese Pharmacopoeia L- cysteine ...
Issue/Submission Date
2008-02-26
2014-08-05
2008-01-09
Supporting Info
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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Didanosine bulk powder at Chuo-ku, ...
Issue/Submission Date
2006-05-18
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
 
Filing Details
Didanosine bulk powder at Chuo-ku, ...
Issue/Submission Date
2006-05-18
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
DIPYRIDAMOLE
Issue/Submission Date
1980-06-20
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
DIPYRIDAMOLE
Issue/Submission Date
1980-06-20
Supporting Info
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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Japanese Pharmacopoeia L- cysteine ...
Issue/Submission Date
2008-01-09
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
 
Filing Details
Japanese Pharmacopoeia L- cysteine ...
Issue/Submission Date
2008-01-09
Supporting Info
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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Japanese Pharmacopoeia L- valine (p...
Issue/Submission Date
2005-11-01
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
 
Filing Details
Japanese Pharmacopoeia L- valine (p...
Issue/Submission Date
2005-11-01
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
GALANTAMINE HBR
Issue/Submission Date
2005-01-28
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
GALANTAMINE HBR
Issue/Submission Date
2005-01-28
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
GALANTAMINE HYDROBROMIDE
Issue/Submission Date
2005-03-03
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
GALANTAMINE HYDROBROMIDE
Issue/Submission Date
2005-03-03
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
L-ALANYL-GLUTAMINE
Issue/Submission Date
2009-03-05
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
L-ALANYL-GLUTAMINE
Issue/Submission Date
2009-03-05
Supporting Info
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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Histidine
Issue/Submission Date
2018-06-22
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
VALID
 
Filing Details
Histidine
Issue/Submission Date
2018-06-22
Supporting Info
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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Histidine SA
Issue/Submission Date
2018-05-18
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
VALID
 
Filing Details
Histidine SA
Issue/Submission Date
2018-05-18
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
IRBESARTAN CRUDE
Issue/Submission Date
1998-02-20
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
IRBESARTAN CRUDE
Issue/Submission Date
1998-02-20
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
L-SERINE (PROCESS II)
Issue/Submission Date
2017-03-21
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Serine
Issue/Submission Date
2018-05-17
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
VALID
 
Filing Details
L-SERINE (PROCESS II)
Serine
Issue/Submission Date
2017-03-21
2018-05-17
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
L-ALANINE
Issue/Submission Date
2015-02-23
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Alanine
Issue/Submission Date
2018-06-22
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Japanese Pharmacopoeia L- alanine (...
Issue/Submission Date
2011-04-28
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Filing Details
L-ALANINE
Alanine
Japanese Pharmacopoeia L- alanine (...
Issue/Submission Date
2015-02-23
2018-06-22
2011-04-28
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
L-ALANINE
Issue/Submission Date
2017-03-21
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Alanine II
Issue/Submission Date
2018-11-09
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
VALID
 
Filing Details
L-ALANINE
Alanine II
Issue/Submission Date
2017-03-21
2018-11-09
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
L-ARGININE
Issue/Submission Date
2017-04-20
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Japanese Pharmacopoeia L- arginine ...
Issue/Submission Date
2006-11-10
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
L-ARGININE
Japanese Pharmacopoeia L- arginine ...
Issue/Submission Date
2017-04-20
2006-11-10
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
L-ARGININE MONOHYDROCHLORIDE
Issue/Submission Date
1963-12-10
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Arginine hydrochloride
Issue/Submission Date
2014-10-10
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Japanese Pharmacopoeia L- arginine ...
Issue/Submission Date
2006-07-20
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
VALID
 
Filing Details
L-ARGININE MONOHYDROCHLORIDE
Arginine hydrochloride
Japanese Pharmacopoeia L- arginine ...
Issue/Submission Date
1963-12-10
2014-10-10
2006-07-20
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
L-ARGININE MONOHYDROCHLORIDE
Issue/Submission Date
2017-04-20
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Arginine
Issue/Submission Date
2014-09-30
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
VALID
 
Filing Details
L-ARGININE MONOHYDROCHLORIDE
Arginine
Issue/Submission Date
2017-04-20
2014-09-30
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
L-ASPARTIC ACID
Issue/Submission Date
2017-04-20
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Japanese Pharmacopoeia L- aspartic ...
Issue/Submission Date
2006-07-20
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
L-ASPARTIC ACID
Japanese Pharmacopoeia L- aspartic ...
Issue/Submission Date
2017-04-20
2006-07-20
Supporting Info
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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
L- cysteine ​​hydrochloride (mo...
Issue/Submission Date
2005-09-09
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
 
Filing Details
L- cysteine ​​hydrochloride (mo...
Issue/Submission Date
2005-09-09
Supporting Info
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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Outsiders regulations L- cystine (p...
Issue/Submission Date
2006-12-18
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
 
Filing Details
Outsiders regulations L- cystine (p...
Issue/Submission Date
2006-12-18
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
L-GLUTAMIC ACID
Issue/Submission Date
2017-04-20
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Glutamic Acid
Issue/Submission Date
2006-09-29
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Japanese Pharmacopoeia L- glutamic ...
Issue/Submission Date
2012-01-18
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
VALID
 
Filing Details
L-GLUTAMIC ACID
Glutamic Acid
Japanese Pharmacopoeia L- glutamic ...
Issue/Submission Date
2017-04-20
2006-09-29
2012-01-18
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
L-GLUTAMINE
Issue/Submission Date
2006-08-07
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Japanese Pharmacopoeia L- glutamine...
Issue/Submission Date
2008-11-25
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
L-GLUTAMINE
Japanese Pharmacopoeia L- glutamine...
Issue/Submission Date
2006-08-07
2008-11-25
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
L-HISTIDINE
Issue/Submission Date
2017-03-21
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Histidine Hydrochloride Monohydrate
Issue/Submission Date
2018-06-22
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Japanese Pharmacopoeia L- histidine...
Issue/Submission Date
2012-01-18
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
VALID
 
Filing Details
L-HISTIDINE
Histidine Hydrochloride Monohydrate
Japanese Pharmacopoeia L- histidine...
Issue/Submission Date
2017-03-21
2018-06-22
2012-01-18
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
L-HISTIDINE MONOHYDROCHLORIDE MONOH...
Issue/Submission Date
2017-03-21
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Japanese Pharmacopoeia L- histidine...
Issue/Submission Date
2012-01-18
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
L-HISTIDINE MONOHYDROCHLORIDE MONOH...
Japanese Pharmacopoeia L- histidine...
Issue/Submission Date
2017-03-21
2012-01-18
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
L-ISOLEUCINE
Issue/Submission Date
2008-07-17
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Isoleucine SA
Issue/Submission Date
2015-02-13
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Japanese Pharmacopoeia L- isoleucin...
Issue/Submission Date
2014-05-09
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Filing Details
L-ISOLEUCINE
Isoleucine SA
Japanese Pharmacopoeia L- isoleucin...
Issue/Submission Date
2008-07-17
2015-02-13
2014-05-09
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
L-ISOLEUCINE
Issue/Submission Date
2015-02-23
Supporting Info
CEP/COS

Application Number
Status
WITHDRAWN BY HOLDER
Filing Details
Isoleucine
Issue/Submission Date
2013-09-25
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
WITHDRAWN BY HOLDER
 
Filing Details
L-ISOLEUCINE
Isoleucine
Issue/Submission Date
2015-02-23
2013-09-25
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
L-LEUCINE
Issue/Submission Date
2008-04-29
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Leucine
Issue/Submission Date
2018-02-23
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Japanese Pharmacopoeia L- leucine (...
Issue/Submission Date
2005-11-01
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
VALID
 
Filing Details
L-LEUCINE
Leucine
Japanese Pharmacopoeia L- leucine (...
Issue/Submission Date
2008-04-29
2018-02-23
2005-11-01
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
L-LEUCINE
Issue/Submission Date
2008-07-03
Supporting Info
CEP/COS

Application Number
Status
WITHDRAWN BY HOLDER
Filing Details
Leucine
Issue/Submission Date
2008-03-07
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
WITHDRAWN BY HOLDER
 
Filing Details
L-LEUCINE
Leucine
Issue/Submission Date
2008-07-03
2008-03-07
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
L-LEUCINE
Issue/Submission Date
2017-03-21
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Leucine
Issue/Submission Date
2018-05-17
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
VALID
 
Filing Details
L-LEUCINE
Leucine
Issue/Submission Date
2017-03-21
2018-05-17
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
L-LYSINE ACETATE
Issue/Submission Date
2017-03-21
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Lysine acetate
Issue/Submission Date
2015-02-12
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Japanese Pharmacopoeia L- lysine ac...
Issue/Submission Date
2015-04-21
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
VALID
 
Filing Details
L-LYSINE ACETATE
Lysine acetate
Japanese Pharmacopoeia L- lysine ac...
Issue/Submission Date
2017-03-21
2015-02-12
2015-04-21
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
L-LYSINE ACETATE
Issue/Submission Date
2017-04-20
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Lysine acetate NC
Issue/Submission Date
2018-05-17
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
VALID
 
Filing Details
L-LYSINE ACETATE
Lysine acetate NC
Issue/Submission Date
2017-04-20
2018-05-17
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
L-LYSINE MONOHYDROCHLORIDE
Issue/Submission Date
2012-08-02
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Japanese Pharmacopoeia L- lysine hy...
Issue/Submission Date
2011-03-10
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
L-LYSINE MONOHYDROCHLORIDE
Japanese Pharmacopoeia L- lysine hy...
Issue/Submission Date
2012-08-02
2011-03-10
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
L-LYSINE MONOHYDROCHLORIDE
Issue/Submission Date
2017-04-20
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
L-LYSINE MONOHYDROCHLORIDE
Issue/Submission Date
2017-04-20
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
L-PHENYLALANINE
Issue/Submission Date
2015-02-23
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Phenylalanine SA
Issue/Submission Date
2015-06-15
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Japanese Pharmacopoeia L- phenylala...
Issue/Submission Date
2014-05-09
Supporting Info
Written Confirmation

Application Number
Status
Filing Details