Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 083734
Company: ANI PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROBENECID AND COLCHICINE COLCHICINE; PROBENECID 0.5MG;500MG 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
06/12/1978 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
07/29/2002 SUPPL-47 Manufacturing (CMC)-Facility

Label is not available on this site.

03/12/2002 SUPPL-46 Manufacturing (CMC)-Facility

Label is not available on this site.

07/11/2001 SUPPL-44 Manufacturing (CMC)-Facility

Label is not available on this site.

01/28/2000 SUPPL-43 Manufacturing (CMC)-Facility

Label is not available on this site.

07/11/2001 SUPPL-42 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

07/11/2001 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.

07/11/2001 SUPPL-40 Manufacturing (CMC)-Facility

Label is not available on this site.

08/20/1999 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

12/09/1998 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

05/30/1997 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

08/03/1993 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

02/05/1996 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

01/05/1990 SUPPL-34 Labeling

Label is not available on this site.

01/20/1988 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

01/20/1988 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

01/20/1988 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

03/03/1987 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

03/03/1987 SUPPL-29 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