Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204503
Company: DR REDDYS

Products on ANDA 204503

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	1.75MG	TABLET;SUBLINGUAL	Prescription	AB	No	No
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	3.5MG	TABLET;SUBLINGUAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204503

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/18/2016	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 204503

ZOLPIDEM TARTRATE

TABLET;SUBLINGUAL; 1.75MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	1.75MG	TABLET;SUBLINGUAL	Prescription	No	AB	204503	DR REDDYS
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	1.75MG	TABLET;SUBLINGUAL	Prescription	No	AB	204299	NOVEL LABS INC
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	1.75MG	TABLET;SUBLINGUAL	Prescription	No	AB	204229	PAR PHARM INC

TABLET;SUBLINGUAL; 3.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	3.5MG	TABLET;SUBLINGUAL	Prescription	No	AB	204503	DR REDDYS
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	3.5MG	TABLET;SUBLINGUAL	Prescription	No	AB	204299	NOVEL LABS INC
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	3.5MG	TABLET;SUBLINGUAL	Prescription	No	AB	204229	PAR PHARM INC