Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 081083
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 750MG;7.5MG 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
08/30/1991 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
01/09/2008 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

08/08/2002 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

08/08/2002 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

05/21/2002 SUPPL-18 Manufacturing (CMC)-Facility

Label is not available on this site.

09/05/2001 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

10/27/1999 SUPPL-16 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

03/29/2000 SUPPL-15 Labeling

Label is not available on this site.

10/29/1998 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

10/07/1998 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

08/08/1997 SUPPL-12 Labeling

Label is not available on this site.

12/04/1997 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

12/04/1997 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

12/04/1997 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

05/10/1996 SUPPL-7 Labeling

Label is not available on this site.

12/22/1995 SUPPL-5 Labeling

Label is not available on this site.

08/21/1995 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

10/20/1994 SUPPL-3 Labeling

Label is not available on this site.

10/22/1993 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

09/08/1992 SUPPL-1 Labeling

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