Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 071977
Company: ANI PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE 90MG 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
04/06/1988 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
05/24/2002 SUPPL-10 Labeling

Label is not available on this site.

07/07/2000 SUPPL-9 Manufacturing (CMC)-Facility

Label is not available on this site.

11/22/1999 SUPPL-8 Labeling

Label is not available on this site.

06/10/1999 SUPPL-7 Labeling

Label is not available on this site.

10/20/1998 SUPPL-6 Labeling

Label is not available on this site.

05/11/1994 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

04/23/1992 SUPPL-4 Labeling

Label is not available on this site.

10/24/1991 SUPPL-3 Labeling

Label is not available on this site.

08/30/1988 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