Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 089271
Company: MIKART
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 500MG;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
07/16/1986 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
08/13/2002 SUPPL-39 Manufacturing (CMC)-Facility

Label is not available on this site.

09/09/1998 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

07/31/1998 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

01/14/1998 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

09/18/1996 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

09/18/1996 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

08/31/2000 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

08/31/2000 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

08/31/2000 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

02/07/1997 SUPPL-30 Labeling

Label is not available on this site.

08/31/2000 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

07/19/1995 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

02/08/1995 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

05/13/1992 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

01/06/1992 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

01/06/1992 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

01/06/1992 SUPPL-23 Labeling

Label is not available on this site.

01/06/1992 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

01/06/1992 SUPPL-21 Labeling

Label is not available on this site.

01/06/1992 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

02/21/1991 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

11/21/1989 SUPPL-17 Labeling

Label is not available on this site.

04/11/1989 SUPPL-16 Bioequivalence

Label is not available on this site.

09/14/1990 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

09/14/1990 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

03/02/1989 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

03/02/1989 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

03/02/1989 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

07/20/1993 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

07/20/1993 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

06/17/1988 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

04/15/1988 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

05/12/1988 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