An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 076539
Company: FRESENIUS KABI USA

Other Important Information from FDA

Products on ANDA 076539

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VALPROATE SODIUM	VALPROATE SODIUM	EQ 100MG BASE/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076539

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/26/2003	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/04/2024	SUPPL-12	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
04/04/2024	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
10/11/2016	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
12/22/2015	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
12/22/2015	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
12/22/2015	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
12/22/2015	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
12/22/2015	SUPPL-5	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 076539

VALPROATE SODIUM

INJECTABLE;INJECTION; EQ 100MG BASE/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
VALPROATE SODIUM	VALPROATE SODIUM	EQ 100MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	076539	FRESENIUS KABI USA
VALPROATE SODIUM	VALPROATE SODIUM	EQ 100MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	078523	HIKMA FARMACEUTICA
VALPROATE SODIUM	VALPROATE SODIUM	EQ 100MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	076295	SAGENT

Top