Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 071238
Company: WATSON LABS
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
04/30/1987 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-26 Labeling-Package Insert

Label is not available on this site.

03/17/2008 SUPPL-22 Labeling

Label is not available on this site.

07/02/2007 SUPPL-19 Labeling

Label is not available on this site.

01/26/2012 SUPPL-18 Labeling

Label is not available on this site.

04/14/2004 SUPPL-16 Labeling

Label is not available on this site.

04/25/2001 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

12/15/2000 SUPPL-14 Labeling

Label is not available on this site.

12/16/1997 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

12/19/1995 SUPPL-11 Labeling

Label is not available on this site.

08/27/1993 SUPPL-10 Labeling

Label is not available on this site.

05/22/1991 SUPPL-9 Labeling

Label is not available on this site.

11/19/1990 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

05/31/1991 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

06/29/1990 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

06/03/1988 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

06/03/1988 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

11/06/1987 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

11/06/1987 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English