Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 072162
Company: HERITAGE PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MAPROTILINE HYDROCHLORIDE MAPROTILINE HYDROCHLORIDE 25MG 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
06/01/1988 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
07/17/2014 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

11/07/2002 SUPPL-8 Manufacturing (CMC)-Facility

Label is not available on this site.

11/10/1999 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/26/1998 SUPPL-6 Labeling

Label is not available on this site.

06/04/1992 SUPPL-5 Labeling

Label is not available on this site.

05/20/1992 SUPPL-4 Labeling

Label is not available on this site.

01/18/1991 SUPPL-3 Labeling

Label is not available on this site.

04/26/1989 SUPPL-2 Bioequivalence

Label is not available on this site.

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