Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 071364
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACETYLCYSTEINE ACETYLCYSTEINE 10% SOLUTION;INHALATION, 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
05/01/1989 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
01/18/2002 SUPPL-9 Labeling

Label is not available on this site.

01/18/2002 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/17/2001 SUPPL-7 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

05/04/2001 SUPPL-6 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

06/10/1998 SUPPL-5 Labeling

Label is not available on this site.

11/18/1998 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

03/13/1998 SUPPL-3 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