Drugs@FDA: FDA Approved Drug Products

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

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 INC
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

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 INC
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

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