Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078129
Company: HIKMA

• Other Important Information from FDA

Products on ANDA 078129

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	5MG	TABLET;ORAL	Discontinued	None	No	No
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	10MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078129

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/30/2008	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
09/13/2022	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
03/20/2013	SUPPL-3	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/03/2008	SUPPL-1	Labeling		Label is not available on this site.