Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 089474
Company: WEST-WARD PHARMS INT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROTAMINE SULFATE PROTAMINE SULFATE 10MG/ML 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
11/05/1986 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
06/29/2000 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

03/29/1999 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

11/05/1998 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

01/30/1996 SUPPL-10 Labeling

Label is not available on this site.

12/28/1994 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

12/26/1990 SUPPL-8 Labeling

Label is not available on this site.

08/14/1992 SUPPL-6 Labeling

Label is not available on this site.

05/17/1989 SUPPL-5 Labeling

Label is not available on this site.

10/28/1988 SUPPL-4 Labeling

Label is not available on this site.

11/06/1987 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

03/08/1988 SUPPL-2 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