Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 017466
Company: SANOFI AVENTIS US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BRICANYL TERBUTALINE SULFATE 1MG/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
03/25/1974 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
10/08/1997 SUPPL-24 Efficacy-New Patient Population

Label is not available on this site.

12/07/2007 SUPPL-23 Labeling

Label is not available on this site.

03/23/1998 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

02/03/1988 SUPPL-21 Labeling

Label is not available on this site.

05/30/1989 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

07/24/1986 SUPPL-19 Labeling

Label is not available on this site.

06/25/1985 SUPPL-18 Labeling

Label is not available on this site.

11/02/1983 SUPPL-17 Labeling

Label is not available on this site.

03/01/1983 SUPPL-16 Labeling

Label is not available on this site.

07/08/1982 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

02/02/1982 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

01/19/1981 SUPPL-13 Labeling

Label is not available on this site.

11/24/1980 SUPPL-12 Labeling

Label is not available on this site.

03/03/1981 SUPPL-11 Labeling

Label is not available on this site.

11/09/1979 SUPPL-10 Labeling

Label is not available on this site.

08/07/1979 SUPPL-9 Labeling

Label is not available on this site.

10/12/1978 SUPPL-8 Labeling

Label is not available on this site.

12/21/1976 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

12/07/2007 SUPPL-6 Labeling

Label is not available on this site.

12/07/2007 SUPPL-5 Efficacy

Label is not available on this site.

10/03/1975 SUPPL-4 Labeling

Label is not available on this site.

07/21/1975 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

12/07/2007 SUPPL-2 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