Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 088921
Company: ANI PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHLORPROPAMIDE CHLORPROPAMIDE 100MG 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
04/12/1985 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
08/04/2003 SUPPL-19 Labeling

Label is not available on this site.

08/09/2001 SUPPL-18 Labeling

Label is not available on this site.

05/29/2001 SUPPL-17 Manufacturing (CMC)-Facility

Label is not available on this site.

03/21/2001 SUPPL-16 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

07/07/2000 SUPPL-15 Manufacturing (CMC)-Facility

Label is not available on this site.

04/22/1994 SUPPL-14 Labeling

Label is not available on this site.

05/11/1994 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

02/25/1993 SUPPL-12 Labeling

Label is not available on this site.

07/29/1992 SUPPL-11 Labeling

Label is not available on this site.

03/24/1992 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

05/29/1991 SUPPL-9 Labeling

Label is not available on this site.

11/17/1988 SUPPL-8 Labeling

Label is not available on this site.

06/17/1987 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

07/30/1986 SUPPL-4 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