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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078989
Company: UNICHEM

Other Important Information from FDA

Products on ANDA 078989

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZALEPLON	ZALEPLON	5MG	CAPSULE;ORAL	Prescription	AB	No	No
ZALEPLON	ZALEPLON	10MG	CAPSULE;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078989

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/06/2008	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078989s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/03/2019	SUPPL-10	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/03/2019	SUPPL-9	Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
03/12/2014	SUPPL-3	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 078989

ZALEPLON

CAPSULE;ORAL; 5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ZALEPLON	ZALEPLON	5MG	CAPSULE;ORAL	Prescription	No	AB	078829	AUROBINDO PHARMA
ZALEPLON	ZALEPLON	5MG	CAPSULE;ORAL	Prescription	No	AB	077505	CHARTWELL MOLECULAR
ZALEPLON	ZALEPLON	5MG	CAPSULE;ORAL	Prescription	No	AB	077237	HIKMA
ZALEPLON	ZALEPLON	5MG	CAPSULE;ORAL	Prescription	No	AB	090374	ORBION PHARMS
ZALEPLON	ZALEPLON	5MG	CAPSULE;ORAL	Prescription	No	AB	078989	UNICHEM

CAPSULE;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ZALEPLON	ZALEPLON	10MG	CAPSULE;ORAL	Prescription	No	AB	078829	AUROBINDO PHARMA
ZALEPLON	ZALEPLON	10MG	CAPSULE;ORAL	Prescription	No	AB	077505	CHARTWELL MOLECULAR
ZALEPLON	ZALEPLON	10MG	CAPSULE;ORAL	Prescription	No	AB	077237	HIKMA
ZALEPLON	ZALEPLON	10MG	CAPSULE;ORAL	Prescription	No	AB	090374	ORBION PHARMS
ZALEPLON	ZALEPLON	10MG	CAPSULE;ORAL	Prescription	No	AB	078989	UNICHEM

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