Is there a generic for Valproate sodium?

Yes. The FDA Orange Book lists 4 approved generic (ANDA) applications for Valproate sodium, referencing the brand DEPACON. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Valproate sodium?

DEPACON (NDA 020593, ABBVIE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Valproate sodium are approved?

Valproate sodium is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Valproate sodium

Valproate sodium is approved as 1 brand and 4 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:DEPACON · NDA 020593

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
DEPACONRLD	ABBVIE	NDA 020593	—	Dec 30, 1996

Generic (ANDA) products (4)

Product	Applicant	Application	TE	Approved
VALPROATE SODIUM	PHARMOBEDIENT	ANDA 208120	—	Dec 22, 2021
VALPROATE SODIUM	HIKMA FARMACEUTICA	ANDA 078523	AP	Feb 17, 2010
VALPROATE SODIUM	FRESENIUS KABI USA	ANDA 076539	AP	Jun 26, 2003
VALPROATE SODIUM	SAGENT	ANDA 076295	AP	Nov 14, 2002

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Valproate sodium — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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