Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 072879
Company: UPSHER-SMITH LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMOXAPINE AMOXAPINE 150MG 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
06/28/1991 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-14 Labeling-Patient Package Insert

Label is not available on this site.

03/25/2002 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

05/22/2001 SUPPL-9 Labeling

Label is not available on this site.

03/23/2001 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

09/18/2000 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

05/05/1999 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

09/17/1997 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

04/10/1995 SUPPL-4 Labeling

Label is not available on this site.

01/24/1994 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

07/29/1993 SUPPL-2 Labeling

Label is not available on this site.

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