Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204299
Company: NOVEL LABS INC

Products on ANDA 204299

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	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204299

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/03/2015	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
11/29/2019	SUPPL-7	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
11/29/2019	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 204299

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	PH HEALTH

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	PH HEALTH