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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075877
Company: IMPAX LABS

Other Important Information from FDA

Products on ANDA 075877

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TERBUTALINE SULFATE	TERBUTALINE SULFATE	2.5MG	TABLET;ORAL	Prescription	AB	No	No
TERBUTALINE SULFATE	TERBUTALINE SULFATE	5MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075877

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/26/2001	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
04/08/2011	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 075877

TERBUTALINE SULFATE

TABLET;ORAL; 2.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BRETHINE	TERBUTALINE SULFATE	2.5MG	TABLET;ORAL	Prescription	Yes	AB	017849	ANI PHARMS
TERBUTALINE SULFATE	TERBUTALINE SULFATE	2.5MG	TABLET;ORAL	Prescription	No	AB	075877	IMPAX LABS
TERBUTALINE SULFATE	TERBUTALINE SULFATE	2.5MG	TABLET;ORAL	Prescription	No	AB	077152	LANNETT CO INC
TERBUTALINE SULFATE	TERBUTALINE SULFATE	2.5MG	TABLET;ORAL	Prescription	No	AB	211832	TWI PHARMS

TABLET;ORAL; 5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BRETHINE	TERBUTALINE SULFATE	5MG	TABLET;ORAL	Prescription	Yes	AB	017849	ANI PHARMS
TERBUTALINE SULFATE	TERBUTALINE SULFATE	5MG	TABLET;ORAL	Prescription	No	AB	075877	IMPAX LABS
TERBUTALINE SULFATE	TERBUTALINE SULFATE	5MG	TABLET;ORAL	Prescription	No	AB	077152	LANNETT CO INC
TERBUTALINE SULFATE	TERBUTALINE SULFATE	5MG	TABLET;ORAL	Prescription	No	AB	211832	TWI PHARMS

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