Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078147
Company: HIKMA PHARMS

• Other Important Information from FDA

Products on ANDA 078147

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078147

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/25/2008	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
12/06/2019	SUPPL-2	Labeling-Package Insert		Label is not available on this site.