Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 007504
Company: SANOFI AVENTIS US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACTHAR CORTICOTROPIN 25 UNITS/VIAL INJECTABLE;INJECTION Discontinued None No No
ACTHAR CORTICOTROPIN 40 UNITS/VIAL 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
07/03/1950 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/20/1992 SUPPL-20 Labeling

Label is not available on this site.

08/24/1983 SUPPL-19 Labeling

Label is not available on this site.

03/26/1981 SUPPL-18 Labeling

Label is not available on this site.

06/26/1979 SUPPL-16 Labeling

Label is not available on this site.

06/26/1979 SUPPL-15 Labeling

Label is not available on this site.

10/05/1977 SUPPL-14 Labeling

Label is not available on this site.

05/25/1977 SUPPL-13 Labeling

Label is not available on this site.

12/30/1975 SUPPL-10 Labeling

Label is not available on this site.

10/03/1975 SUPPL-9 Labeling

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