Valproate | FDA Orange Book | Approved Drug Product List

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BioFlorida Conference

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Dosage Strength : 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

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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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BioFlorida Conference

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Dosage Strength : 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

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

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

BioFlorida Conference

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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BioFlorida Conference

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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BioFlorida Conference

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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BioFlorida Conference

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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BioFlorida Conference

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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BioFlorida Conference

Not Confirmed

U.S.A

RLD :

TE Code :