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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Fermion Oy

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6-MERCAPTOPURINE

ACETONIDE HYDROLYSATE CODE 2543

ALPRAZOLAM

AZATHIOPRINE

BUSPIRONE HYDROCHLORIDE

Benzerazide hydrochloride

CARBIDOPA

CITALOPRAM HYDROBROMIDE

CROMOLYN SODIUM

CYCLOBENZAPRINE HCL

CYCLOPHOSPHAMIDE ORAL GRADE

Cabozantinib

DEXMEDETOMIDINE HYDROCHLORIDE

DILTIAZEM HCL

ENTACAPONE

FLUOXETINE HYDROCHLORIDE USP

FLUTAMIDE

Formoterol

Formoterol fumarate dihydrate Micronised

GLIPIZIDE

HYDROXYCHLOROQUINE SULPHATE

Hydrochloric acid dexmedetomidine (production only)

IRINOTECAN HYDROCHLORIDE

Irinotecan hydrochloride trihydrate

LEUCOVORIN CALCIUM

LEVOLEUCOVORIN CALCIUM

LEVOSIMENDAN

METHOTREXATE

METHOTREXATE DISODIUM

Methotrexate disodium salt

NADOLOL

NINTEDANIB ESYLATE

Niraparib

Nitrofurantoin

ODM-201

OSPEMIFENE

PRAZOSIN HYDROCHLORIDE

PROPAFENONE HCL

QUETIAPINE FUMARATE "ALTERNATIVE PROCESS"

QUETIAPINE FUMARATE A PHARMACEUTICAL INGREDIENT

RUCAPARIB

SULPHINPYRAZONE USP 80

Salmeterol

Salmeterol Xinafoate

Salmeterol xinafoate Micronised

TAMOXIFEN CITRATE

TAMSULOSIN HYDROCHLORIDE

TOLNAFTATE USP

TOREMIFENE CITRATE

TRAZODONE HYDROCHLORIDE

Tamoxifen

VEMURAFENIB

VERAPAMIL HCL BP 80 ADD. 82

brivaracetam

eluxadoline

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Status - Active

Status - Inactive

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VALID

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218MF10833

218MF10968

219MF10128

219MF10302

219MF10359

219MF10365

219MF10383

220MF10025

222MF10048

223MF10083

229MF10159

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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
6-MERCAPTOPURINE
Issue/Submission Date
2001-01-15
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Mercaptopurine
Issue/Submission Date
2016-10-27
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Mercaptopurine hydrate at Koivu-Man...
Issue/Submission Date
2006-12-01
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
6-MERCAPTOPURINE
Mercaptopurine
Mercaptopurine hydrate at Koivu-Man...
Issue/Submission Date
2001-01-15
2016-10-27
2006-12-01
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
ALPRAZOLAM
Issue/Submission Date
1991-04-04
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Alprazolam
Issue/Submission Date
2014-08-19
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Alprazolam at Koivu-Mankkaan tie 6A...
Issue/Submission Date
2007-04-18
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
ALPRAZOLAM
Alprazolam
Alprazolam at Koivu-Mankkaan tie 6A...
Issue/Submission Date
1991-04-04
2014-08-19
2007-04-18
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
AZATHIOPRINE
Issue/Submission Date
1984-03-19
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Azathioprine
Issue/Submission Date
2018-10-04
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Azathioprine at Koivu-Mankkaan tie ...
Issue/Submission Date
2007-12-19
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
AZATHIOPRINE
Azathioprine
Azathioprine at Koivu-Mankkaan tie ...
Issue/Submission Date
1984-03-19
2018-10-04
2007-12-19
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
AZATHIOPRINE
Issue/Submission Date
1997-07-11
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
AZATHIOPRINE
Issue/Submission Date
1997-07-11
Supporting Info
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USDMF

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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
Issue/Submission Date
Supporting Info

Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info

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

Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info

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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
BUSPIRONE HYDROCHLORIDE
Issue/Submission Date
1994-10-21
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
BUSPIRONE HYDROCHLORIDE
Issue/Submission Date
1994-10-21
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
Issue/Submission Date
Supporting Info

Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info

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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
CARBIDOPA
Issue/Submission Date
2012-09-14
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Carbidopa
Issue/Submission Date
2017-04-10
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
CARBIDOPA
Carbidopa
Issue/Submission Date
2012-09-14
2017-04-10
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
CITALOPRAM HYDROBROMIDE
Issue/Submission Date
2003-07-11
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
CITALOPRAM HYDROBROMIDE
Issue/Submission Date
2003-07-11
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
CROMOLYN SODIUM
Issue/Submission Date
1992-12-15
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Sodium cromoglicate
Issue/Submission Date
2016-07-06
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Sodium cromoglycate at Koivu-Mankka...
Issue/Submission Date
2011-06-17
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
CROMOLYN SODIUM
Sodium cromoglicate
Sodium cromoglycate at Koivu-Mankka...
Issue/Submission Date
1992-12-15
2016-07-06
2011-06-17
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
CYCLOBENZAPRINE HCL
Issue/Submission Date
1988-10-28
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
CYCLOBENZAPRINE HCL
Issue/Submission Date
1988-10-28
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
CYCLOPHOSPHAMIDE ORAL GRADE
Issue/Submission Date
1978-06-02
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
CYCLOPHOSPHAMIDE ORAL GRADE
Issue/Submission Date
1978-06-02
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
Hydrochloric acid dexmedetomidine (...
Issue/Submission Date
2006-10-20
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
 
Filing Details
Hydrochloric acid dexmedetomidine (...
Issue/Submission Date
2006-10-20
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
DEXMEDETOMIDINE HYDROCHLORIDE
Issue/Submission Date
1998-10-30
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
DEXMEDETOMIDINE HYDROCHLORIDE
Issue/Submission Date
1998-10-30
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
DILTIAZEM HCL
Issue/Submission Date
1985-02-06
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
DILTIAZEM HCL
Issue/Submission Date
1985-02-06
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
Issue/Submission Date
Supporting Info

Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info

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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
ENTACAPONE
Issue/Submission Date
1997-03-26
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
ENTACAPONE
Issue/Submission Date
1997-03-26
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
FLUOXETINE HYDROCHLORIDE USP
Issue/Submission Date
1995-01-26
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Fluoxetine hydrochloride
Issue/Submission Date
2016-02-15
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
FLUOXETINE HYDROCHLORIDE USP
Fluoxetine hydrochloride
Issue/Submission Date
1995-01-26
2016-02-15
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
FLUTAMIDE
Issue/Submission Date
1995-05-23
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Flutamide
Issue/Submission Date
2014-02-06
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
FLUTAMIDE
Flutamide
Issue/Submission Date
1995-05-23
2014-02-06
Supporting Info
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USDMF

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

Application Number
Status
Filing Details
Issue/Submission Date
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Application Number
Status
 
Filing Details
Issue/Submission Date
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
Formoterol fumarate dihydrate Micro...
Issue/Submission Date
2018-08-14
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Formoterol fumarate hydrate at Koiv...
Issue/Submission Date
2017-08-17
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
VALID
 
Filing Details
Formoterol fumarate dihydrate Micro...
Formoterol fumarate hydrate at Koiv...
Issue/Submission Date
2018-08-14
2017-08-17
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
GLIPIZIDE
Issue/Submission Date
2000-12-04
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
GLIPIZIDE
Issue/Submission Date
2000-12-04
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
HYDROXYCHLOROQUINE SULPHATE
Issue/Submission Date
2015-11-24
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Hydroxychloroquine sulfate
Issue/Submission Date
2019-02-20
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
HYDROXYCHLOROQUINE SULPHATE
Hydroxychloroquine sulfate
Issue/Submission Date
2015-11-24
2019-02-20
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
IRINOTECAN HYDROCHLORIDE
Issue/Submission Date
2007-06-29
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Japanese DMF

Application Number
Status
 
Filing Details
Irinotecan hydrochloride hydrate at...
Issue/Submission Date
2008-01-23
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
IRINOTECAN HYDROCHLORIDE
Irinotecan hydrochloride hydrate at...
Issue/Submission Date
2007-06-29
2008-01-23
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
Irinotecan hydrochloride trihydrate
Issue/Submission Date
2018-10-30
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
VALID
 
Filing Details
Irinotecan hydrochloride trihydrate
Issue/Submission Date
2018-10-30
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
Issue/Submission Date
Supporting Info

Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info

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

Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info

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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
LEVOSIMENDAN
Issue/Submission Date
1998-04-24
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
LEVOSIMENDAN
Issue/Submission Date
1998-04-24
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
METHOTREXATE
Issue/Submission Date
1981-08-06
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Methotrexate
Issue/Submission Date
2018-10-26
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Methotrexate at Koivu-Mankkaan tie ...
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
METHOTREXATE
Methotrexate
Methotrexate at Koivu-Mankkaan tie ...
Issue/Submission Date
1981-08-06
2018-10-26
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
METHOTREXATE DISODIUM
Issue/Submission Date
2010-01-29
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
METHOTREXATE DISODIUM
Issue/Submission Date
2010-01-29
Supporting Info
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USDMF

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

Application Number
Status
Filing Details
Issue/Submission Date
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
NADOLOL
Issue/Submission Date
1986-04-04
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Japanese DMF

Application Number
Status
 
Filing Details
Nadolol at Koivu-Mankkaan tie 6A, F...
Issue/Submission Date
2007-09-18
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
NADOLOL
Nadolol at Koivu-Mankkaan tie 6A, F...
Issue/Submission Date
1986-04-04
2007-09-18
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
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NINTEDANIB ESYLATE
Issue/Submission Date
2019-01-02
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CEP/COS

Application Number
Status
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Issue/Submission Date
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Japanese DMF

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Status
 
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Written Confirmation

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Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
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NINTEDANIB ESYLATE
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2019-01-02
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USDMF

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CEP/COS

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Status
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Japanese DMF

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Status
 
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Issue/Submission Date
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Written Confirmation

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Status
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USDMF

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Status
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Issue/Submission Date
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CEP/COS

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Status
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Issue/Submission Date
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Japanese DMF

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Status
 
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Issue/Submission Date
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Written Confirmation

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Status
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
ODM-201
Issue/Submission Date
2014-05-28
Supporting Info
CEP/COS

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

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Status
 
Filing Details
Issue/Submission Date
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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
ODM-201
Issue/Submission Date
2014-05-28
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
OSPEMIFENE
Issue/Submission Date
2011-11-30
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CEP/COS

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Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

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Status
 
Filing Details
Issue/Submission Date
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Written Confirmation

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Status
Filing Details
Issue/Submission Date
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Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
OSPEMIFENE
Issue/Submission Date
2011-11-30
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
PRAZOSIN HYDROCHLORIDE
Issue/Submission Date
1991-06-25
Supporting Info
CEP/COS

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Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

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Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

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Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
PRAZOSIN HYDROCHLORIDE
Issue/Submission Date
1991-06-25
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USDMF

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Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
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PROPAFENONE HCL
Issue/Submission Date
1995-06-29
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Propafenone hydrochloride
Issue/Submission Date
2019-05-02
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
PROPAFENONE HCL
Propafenone hydrochloride
Issue/Submission Date
1995-06-29
2019-05-02
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
QUETIAPINE FUMARATE A PHARMACEUTICA...
Issue/Submission Date
2006-02-02
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Quetiapine Fumarate
Issue/Submission Date
2016-04-11
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
QUETIAPINE FUMARATE A PHARMACEUTICA...
Quetiapine Fumarate
Issue/Submission Date
2006-02-02
2016-04-11
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
QUETIAPINE FUMARATE "ALTERNATIVE PR...
Issue/Submission Date
2011-10-26
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
QUETIAPINE FUMARATE "ALTERNATIVE PR...
Issue/Submission Date
2011-10-26
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USDMF

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Status
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Issue/Submission Date
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

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Status
Filing Details
Issue/Submission Date
Supporting Info

Application Number
Status
 
Filing Details
Issue/Submission Date
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USDMF

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Status
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Issue/Submission Date
Supporting Info

CEP/COS

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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
 
Filing Details
Issue/Submission Date
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USDMF

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

Application Number
Status
Filing Details
Issue/Submission Date
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Application Number
Status
 
Filing Details
Issue/Submission Date
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
SULPHINPYRAZONE USP 80
Issue/Submission Date
1981-06-12
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
SULPHINPYRAZONE USP 80
Issue/Submission Date
1981-06-12
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USDMF

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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
Issue/Submission Date
Supporting Info

Written Confirmation

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Status
Filing Details
Issue/Submission Date
Supporting Info

Application Number
Status
 
Filing Details
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
TAMOXIFEN CITRATE
Issue/Submission Date
1984-04-18
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