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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 071365
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACETYLCYSTEINE ACETYLCYSTEINE 20% 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
11/20/2007 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
11/06/2007 SUPPL-12 Labeling

Label is not available on this site.

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.

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