Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 072420
Company: WATSON PHARMS TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMOXAPINE AMOXAPINE 100MG 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
05/11/1989 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
07/17/2014 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

07/24/2002 SUPPL-13 Manufacturing (CMC)-Facility

Label is not available on this site.

10/05/2001 SUPPL-12 Labeling

Label is not available on this site.

09/05/2001 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

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

Label is not available on this site.

08/01/1997 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

12/27/1995 SUPPL-8 Labeling

Label is not available on this site.

05/04/1995 SUPPL-7 Labeling

Label is not available on this site.

10/08/1993 SUPPL-6 Labeling

Label is not available on this site.

10/08/1993 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

06/02/1992 SUPPL-4 Labeling

Label is not available on this site.

01/17/1991 SUPPL-3 Labeling

Label is not available on this site.

01/07/1991 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

09/12/1989 SUPPL-1 Labeling

Label is not available on this site.

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