Viewing data from:

DIVALPROEX SODIUM

ANDA

DIVALPROEX SODIUM | A203730 | AMNEAL PHARMACEUTICALS

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: DEPAKOTE ER(TE code: AB)

API Supply Chain15 active DMFs5 inactive

14 active API suppliers hold Drug Master Files for this ingredient.

PCASDIVALPROEX SODIUM

DMF 146461999

KATWIJK CHEMIE BVDIVALPROEX SODIUM

DMF 163122002

WOCKHARDT LTDDIVALPROEX SODIUM

DMF 174692004

SCI PHARMTECH INCDIVALPROEX SODIUM

DMF 182852005

SUVEN LIFE SCIENCES LTDDIVALPROEX SODIUM

DMF 192662006

DR REDDYS LABORATORIES LTDDIVALPROEX SODIUM USP

DMF 198712006

SUN PHARMACEUTICAL INDUSTRIES LTDDIVALPROEX SODIUM USP

DMF 198842006

ANJAN DRUG PRIVATE LTDDIVALPROEX SODIUM USP

DMF 200362006

ORBION PHARMACEUTICALS PRIVATE LTDDIVALPROEX SODIUM

DMF 202062007

HARMAN FINOCHEM LTDDIVALPROEX SODIUM USP

DMF 215322008

RAKS PHARMA PVT LTDDIVALPROEX SODIUM USP

DMF 239152010

APITORIA PHARMA PRIVATE LTDDIVALPROEX SODIUM USP

DMF 290972015

HETERO DRUGS LTDDIVALPROEX SODIUM

DMF 314372018

MAITHRI DRUGS PRIVATE LTDDIVALPROEX SODIUM USP

DMF 344402019

SUN PHARMACEUTICAL INDUSTRIES LTDDIVALPROEX SODIUM USP (PROCESS II)

DMF 389112023

SELOC FRNCEInactiveDIVALPROEX SODIUM

DMF 75531988

CILAG AGInactiveDIVALPROEX SODIUM

DMF 162242002

PROCOS SPAInactiveDIVALPROEX SODIUM

DMF 173492004

CHENG FONG CHEMICAL CO LTDInactiveDIVALPROEX SODIUM

DMF 180642005

GENESEN LABS LTDInactiveDIVALPROEX SODIUM

DMF 213412007

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jun 3, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 250MG VALPROIC ACID

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: May 29, 2015

No patent or exclusivity listings for this strength.

#002 — EQ 500MG VALPROIC ACID

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: May 29, 2015