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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074060
Company: HIKMA

Products on ANDA 074060

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VALPROIC ACID	VALPROIC ACID	250MG/5ML	SYRUP;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074060

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/13/1995	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-28	Labeling-Package Insert		Label is not available on this site.
03/30/2026	SUPPL-24	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
03/30/2026	SUPPL-23	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
03/11/2020	SUPPL-20	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
03/11/2020	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
03/11/2020	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
03/11/2020	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
03/11/2020	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
12/01/2015	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
12/01/2015	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
12/01/2015	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
12/01/2015	SUPPL-10	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
12/01/2015	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
12/01/2015	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
12/01/2015	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
12/01/2015	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
01/12/2010	SUPPL-3	Labeling-Container/Carton Labels		Label is not available on this site.
07/05/1996	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

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