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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Alps Pharmaceutical Ind. Co. Ltd.

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Azulene sodium sulfonate

Berberine sulfate

Betamipron

Enoxolone

Fluticasone propionate

Funnel extract variance P (Alps)

Glycyrrhizin acid S \"Alps\"

Japanese Pharmacopoeia Butoropiumu bromide

Japanese Pharmacopoeia berberine chloride hydrate

Japanese Pharmacopoeia dextromethorphan hydrobromide hydrate

Japanese Pharmacopoeia dl- methyl ephedrine hydrochloride

Japanese Pharmacopoeia funnel extract

Japanese Pharmacopoeia licorice extract

Japanese Pharmacopoeia pentoxyverine citrate

Japanese Pharmacopoeia quinine hydrochloride hydrate

Japanese Pharmacopoeia scopolamine hydrobromide hydrate

Japanese Pharmacopoeia-butyl scopolamine bromide

MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN GIFU PREF, JAPAN

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN KAMINO, JAPAN.

MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN MUKAIMACHI, JAPAN.

Magnesium L- aspartic acid, potassium

Methylsulfate N- methyl scopolamine

PHENYLPROPANOLAMINE HYDROCHLORIDE

PROTAMINE SULFATE

Panthenol

Peony root extract

Pepper extract -Z

Plantain extract

Prednisolone valerate acetate

Rutoside trihydrate

Rutoside trihydrate Uncaria

SENNA GLYCOSIDES, CA 60%

SENNOSIDES USP

SENNOSIDES(60)

Senna extract

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Status - Inactive

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VALID

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217MF11020

217MF11022

217MF11027

217MF11029

217MF11030

217MF11040

217MF11042

217MF11044

217MF11048

217MF11049

217MF11051

217MF11055

217MF11057

217MF11062

217MF11063

219MF10163

220MF10121

221MF10164

221MF10172

221MF10173

221MF10207

222MF10105

224MF10062

224MF10093

225MF10025

227MF10032

228MF10079

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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
Funnel extract variance P (Alps) at...
Issue/Submission Date
2005-12-02
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
 
Filing Details
Funnel extract variance P (Alps) at...
Issue/Submission Date
2005-12-02
Supporting Info
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USDMF

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Status
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CEP/COS

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

Application Number
Status
 
Filing Details
Azulene sodium sulfonate at Gifu Pr...
Issue/Submission Date
2005-12-02
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
 
Filing Details
Azulene sodium sulfonate at Gifu Pr...
Issue/Submission Date
2005-12-02
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USDMF

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Status
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Issue/Submission Date
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CEP/COS

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

Application Number
Status
 
Filing Details
Japanese Pharmacopoeia berberine ch...
Issue/Submission Date
2009-09-24
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
 
Filing Details
Japanese Pharmacopoeia berberine ch...
Issue/Submission Date
2009-09-24
Supporting Info

BERBERINESULFATE

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USDMF

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Status
Filing Details
Issue/Submission Date
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CEP/COS

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

Application Number
Status
 
Filing Details
Berberine sulfate at Gifu Prefectur...
Issue/Submission Date
2005-12-02
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
 
Filing Details
Berberine sulfate at Gifu Prefectur...
Issue/Submission Date
2005-12-02
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USDMF

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Status
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Supporting Info
CEP/COS

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

Application Number
Status
 
Filing Details
Pepper extract -Z at Gifu Prefectur...
Issue/Submission Date
2005-12-02
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
 
Filing Details
Pepper extract -Z at Gifu Prefectur...
Issue/Submission Date
2005-12-02
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
Japanese Pharmacopoeia pentoxyverin...
Issue/Submission Date
2013-02-13
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
 
Filing Details
Japanese Pharmacopoeia pentoxyverin...
Issue/Submission Date
2013-02-13
Supporting Info
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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
Senna extract at Gifu Prefecture Hi...
Issue/Submission Date
2005-12-02
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
 
Filing Details
Senna extract at Gifu Prefecture Hi...
Issue/Submission Date
2005-12-02
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
Japanese Pharmacopoeia dextromethor...
Issue/Submission Date
2008-04-28
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
 
Filing Details
Japanese Pharmacopoeia dextromethor...
Issue/Submission Date
2008-04-28
Supporting Info
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USDMF

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

Application Number
Status
VALID
Filing Details
Enoxolone
Issue/Submission Date
2018-08-01
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Glycyrrhetinic acid at Gifu Prefect...
Issue/Submission Date
2016-04-06
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
VALID
 
Filing Details
Enoxolone
Glycyrrhetinic acid at Gifu Prefect...
Issue/Submission Date
2018-08-01
2016-04-06
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
Japanese Pharmacopoeia dl- methyl e...
Issue/Submission Date
2009-07-30
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
 
Filing Details
Japanese Pharmacopoeia dl- methyl e...
Issue/Submission Date
2009-07-30
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
Fluticasone propionate at Gifu Pref...
Issue/Submission Date
2012-04-25
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
 
Filing Details
Fluticasone propionate at Gifu Pref...
Issue/Submission Date
2012-04-25
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
Japanese Pharmacopoeia licorice ext...
Issue/Submission Date
2005-12-02
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
 
Filing Details
Japanese Pharmacopoeia licorice ext...
Issue/Submission Date
2005-12-02
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
Glycyrrhizin acid S "Alps" at Gifu ...
Issue/Submission Date
2005-12-02
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
 
Filing Details
Glycyrrhizin acid S "Alps" at Gifu ...
Issue/Submission Date
2005-12-02
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
Japanese Pharmacopoeia funnel extra...
Issue/Submission Date
2005-12-02
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
 
Filing Details
Japanese Pharmacopoeia funnel extra...
Issue/Submission Date
2005-12-02
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
Magnesium L- aspartic acid, potassi...
Issue/Submission Date
2005-12-02
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
 
Filing Details
Magnesium L- aspartic acid, potassi...
Issue/Submission Date
2005-12-02
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
Methylsulfate N- methyl scopolamine...
Issue/Submission Date
2005-12-02
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
 
Filing Details
Methylsulfate N- methyl scopolamine...
Issue/Submission Date
2005-12-02
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
Betamipron at Gifu Prefecture Hida ...
Issue/Submission Date
2005-12-02
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
 
Filing Details
Betamipron at Gifu Prefecture Hida ...
Issue/Submission Date
2005-12-02
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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
Panthenol at Gifu Prefecture Hida F...
Issue/Submission Date
2005-12-02
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
 
Filing Details
Panthenol at Gifu Prefecture Hida F...
Issue/Submission Date
2005-12-02
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
PHENYLPROPANOLAMINE HYDROCHLORIDE
Issue/Submission Date
1981-07-08
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
PHENYLPROPANOLAMINE HYDROCHLORIDE
Issue/Submission Date
1981-07-08
Supporting Info
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USDMF

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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
Plantain extract at Gifu Prefecture...
Issue/Submission Date
2005-12-02
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
 
Filing Details
Plantain extract at Gifu Prefecture...
Issue/Submission Date
2005-12-02
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
Prednisolone valerate acetate at Gi...
Issue/Submission Date
2009-07-23
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
 
Filing Details
Prednisolone valerate acetate at Gi...
Issue/Submission Date
2009-07-23
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Unpaid
DMF Review - Complete
Filing Details
PROTAMINE SULFATE
Issue/Submission Date
2007-05-11
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 - Unpaid
DMF Review - Complete
 
Filing Details
PROTAMINE SULFATE
Issue/Submission Date
2007-05-11
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
Japanese Pharmacopoeia quinine hydr...
Issue/Submission Date
2010-03-19
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
 
Filing Details
Japanese Pharmacopoeia quinine hydr...
Issue/Submission Date
2010-03-19
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USDMF

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

Application Number
Status
VALID
Filing Details
Rutoside trihydrate Uncaria
Issue/Submission Date
2018-11-27
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
Rutoside trihydrate Uncaria
Issue/Submission Date
2018-11-27
Supporting Info
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USDMF

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

Application Number
Status
VALID
Filing Details
Rutoside trihydrate
Issue/Submission Date
2013-10-24
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
Rutoside trihydrate
Issue/Submission Date
2013-10-24
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
Japanese Pharmacopoeia-butyl scopol...
Issue/Submission Date
2007-05-21
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
 
Filing Details
Japanese Pharmacopoeia-butyl scopol...
Issue/Submission Date
2007-05-21
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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
Japanese Pharmacopoeia scopolamine ...
Issue/Submission Date
2015-01-23
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
 
Filing Details
Japanese Pharmacopoeia scopolamine ...
Issue/Submission Date
2015-01-23
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USDMF

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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
SENNA GLYCOSIDES, CA 60% at Gifu Pr...
Issue/Submission Date
2012-04-01
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
 
Filing Details
SENNA GLYCOSIDES, CA 60% at Gifu Pr...
Issue/Submission Date
2012-04-01
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
SENNOSIDES USP
Issue/Submission Date
1999-02-23
Supporting Info
CEP/COS

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

Application Number
Status
 
Filing Details
Sen'nosaido calcium S (Alps) at Gif...
Issue/Submission Date
2005-12-02
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
SENNOSIDES USP
Sen'nosaido calcium S (Alps) at Gif...
Issue/Submission Date
1999-02-23
2005-12-02
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
SENNOSIDES(60)
Issue/Submission Date
1999-05-01
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
SENNOSIDES(60)
Issue/Submission Date
1999-05-01
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
Japanese Pharmacopoeia Butoropiumu ...
Issue/Submission Date
2009-07-30
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
 
Filing Details
Japanese Pharmacopoeia Butoropiumu ...
Issue/Submission Date
2009-07-30
Supporting Info

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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 - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
MANUFACTURING SITE, FACILITIES, PER...
Issue/Submission Date
1991-09-03
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 - Unpaid
DMF Review - N/A
 
Filing Details
MANUFACTURING SITE, FACILITIES, PER...
Issue/Submission Date
1991-09-03
Supporting Info

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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
MANUFACTURING SITE, FACILITIES, PER...
Issue/Submission Date
1991-09-03
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 - Unpaid
DMF Review - N/A
 
Filing Details
MANUFACTURING SITE, FACILITIES, PER...
Issue/Submission Date
1991-09-03
Supporting Info

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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
MANUFACTURING SITE, FACILITIES, PER...
Issue/Submission Date
1999-02-23
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 - Unpaid
DMF Review - N/A
 
Filing Details
MANUFACTURING SITE, FACILITIES, PER...
Issue/Submission Date
1999-02-23
Supporting Info

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