Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 072134
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE 25MG;4MG TABLET;ORAL Discontinued None 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
02/15/1989 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
04/11/1996 SUPPL-5 Labeling

Label is not available on this site.

11/04/1993 SUPPL-4 Labeling

Label is not available on this site.

05/31/1989 SUPPL-1 Labeling

Label is not available on this site.

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