Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076295
Company: SAGENT

• Other Important Information from FDA

Products on ANDA 076295

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 076295

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/14/2002	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
10/24/2007	SUPPL-4	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 076295

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