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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078523
Company: HIKMA FARMACEUTICA

Products on ANDA 078523

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	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078523

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/17/2010	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
03/31/2026	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
03/31/2026	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
04/21/2020	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
04/21/2020	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
04/21/2020	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
04/21/2020	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
04/21/2020	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
03/31/2026	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
12/15/2014	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
12/15/2014	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
12/15/2014	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
12/15/2014	SUPPL-4	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 078523

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

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