Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 072987
Company: WATSON LABS TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE;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
03/29/1991 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-17 Labeling-Package Insert

Label is not available on this site.

01/19/2001 SUPPL-16 Labeling

Label is not available on this site.

04/12/2001 SUPPL-15 Manufacturing (CMC)-Facility

Label is not available on this site.

03/21/2000 SUPPL-13 Manufacturing (CMC)-Facility

Label is not available on this site.

05/18/1998 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

08/19/1997 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

07/08/1997 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

05/16/1996 SUPPL-8 Labeling

Label is not available on this site.

12/31/1996 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

12/31/1996 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

04/25/1996 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

07/25/1994 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

08/27/1993 SUPPL-2 Labeling

Label is not available on this site.

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