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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 072621
Company: ROXANE
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
09/30/1992 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
08/28/2000 SUPPL-5 Manufacturing (CMC)-Facility

Label is not available on this site.

05/27/1999 SUPPL-4 Labeling

Label is not available on this site.

04/13/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

04/13/1998 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

08/28/1996 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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