Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 086944
Company: ANI PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIPYRIDAMOLE DIPYRIDAMOLE 50MG TABLET;ORAL Discontinued None No No
DIPYRIDAMOLE DIPYRIDAMOLE 25MG TABLET;ORAL Discontinued None No No
DIPYRIDAMOLE DIPYRIDAMOLE 75MG 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
04/16/1991 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
05/09/2001 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

01/12/1995 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

03/12/1992 SUPPL-34 Labeling

Label is not available on this site.

11/20/1989 SUPPL-32 Labeling

Label is not available on this site.

04/16/1991 SUPPL-31 Labeling

Label is not available on this site.

04/26/1989 SUPPL-30 Bioequivalence

Label is not available on this site.

11/20/1986 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

07/03/1986 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

05/27/1986 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

04/30/1985 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

08/21/1984 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

12/13/1983 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

04/30/1985 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

07/20/1982 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

07/20/1982 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

07/20/1982 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

03/10/1982 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

03/10/1982 SUPPL-14 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