Divalproex Sodium | FDA Orange Book | Approved Drug Product List

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BioAsia

Not Confirmed

U.S.A

RLD : Yes

TE Code :

VALPROIC ACID

Brand Name : DEPAKENE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1982-01-01

Application Number : 18081

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Product Web Link

Corporate PDF

02

REDDYS

India

BioAsia

Attending

DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

India

RLD : No

TE Code : AB

Brand Name : DIVALPROEX SODIUM

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : EQ 500MG VALPROIC ACID

Approval Date : 2012-03-12

Application Number : 90070

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

03

ABBVIE

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BioAsia

Not Confirmed

U.S.A

RLD : Yes

TE Code :

VALPROIC ACID

Brand Name : DEPAKENE

Dosage Form : SYRUP;ORAL

Dosage Strength : 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1982-01-01

Application Number : 18082

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Product Web Link

Corporate PDF

04

ABBVIE

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BioAsia

Not Confirmed

U.S.A

RLD : Yes

TE Code : AB

Brand Name : DEPAKOTE

Dosage Form : TABLET, DELAYED RELEASE;ORAL

Dosage Strength : EQ 250MG VALPROIC ACID

Approval Date : 1983-03-10

Application Number : 18723

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

Product Web Link

Corporate PDF

05

ABBVIE

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BioAsia

Not Confirmed

U.S.A

RLD : Yes

TE Code : AB

Brand Name : DEPAKOTE

Dosage Form : TABLET, DELAYED RELEASE;ORAL

Dosage Strength : EQ 500MG VALPROIC ACID

Approval Date : 1983-03-10

Application Number : 18723

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

Product Web Link

Corporate PDF

06

ABBVIE

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BioAsia

Not Confirmed

U.S.A

RLD : Yes

TE Code : AB

Brand Name : DEPAKOTE

Dosage Form : TABLET, DELAYED RELEASE;ORAL

Dosage Strength : EQ 125MG VALPROIC ACID

Approval Date : 1984-10-26

Application Number : 18723

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

Product Web Link

Corporate PDF

07

ABBVIE

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BioAsia

Not Confirmed

U.S.A

RLD : Yes

TE Code : AB

Brand Name : DEPAKOTE

Dosage Form : CAPSULE, DELAYED REL PELLETS;ORAL

Dosage Strength : EQ 125MG VALPROIC ACID

Approval Date : 1989-09-12

Application Number : 19680

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

Product Web Link

Corporate PDF

08

ABBVIE

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BioAsia

Not Confirmed

U.S.A

RLD : Yes

TE Code : AB

Brand Name : DEPAKOTE ER

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : EQ 500MG VALPROIC ACID

Approval Date : 2000-08-04

Application Number : 21168

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

Product Web Link

Corporate PDF

09

ABBVIE

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BioAsia

Not Confirmed

U.S.A

RLD : Yes

TE Code : AB

Brand Name : DEPAKOTE ER

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : EQ 250MG VALPROIC ACID

Approval Date : 2002-05-31

Application Number : 21168

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

Product Web Link

Corporate PDF

10

ABBVIE INC

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BioAsia

Not Confirmed

U.S.A

RLD :

TE Code :