Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 062757
Company: MYLAN INSTITUTIONAL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MEFOXIN CEFOXITIN SODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Discontinued None No No
MEFOXIN CEFOXITIN SODIUM EQ 2GM BASE/VIAL INJECTABLE;INJECTION 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
01/08/1987 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
01/31/2008 SUPPL-25 Labeling

Label is not available on this site.

12/02/2004 SUPPL-24 Labeling

Label is not available on this site.

02/06/2004 SUPPL-23 Labeling

Label is not available on this site.

02/06/2004 SUPPL-22 Labeling

Label is not available on this site.

09/30/2002 SUPPL-21 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/04/2002 SUPPL-20 Manufacturing (CMC)-Facility

Label is not available on this site.

06/04/2002 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

12/06/2001 SUPPL-18 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

12/17/1999 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

07/11/1997 SUPPL-16 Labeling

Label is not available on this site.

08/22/2002 SUPPL-15 Labeling

Label is not available on this site.

05/08/1996 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

02/26/1996 SUPPL-13 Labeling

Label is not available on this site.

02/18/1999 SUPPL-12 Labeling

Label is not available on this site.

07/16/1996 SUPPL-11 Labeling

Label is not available on this site.

03/20/1995 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

02/26/1996 SUPPL-9 Labeling

Label is not available on this site.

07/11/1997 SUPPL-8 Labeling

Label is not available on this site.

03/10/1992 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

02/10/1992 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

02/10/1992 SUPPL-2 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