Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 086899
Company: ROXANE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ISOETHARINE HYDROCHLORIDE ISOETHARINE HYDROCHLORIDE 1% SOLUTION;INHALATION 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
10/23/1979 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
11/25/1997 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

11/25/1997 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

08/28/1996 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

04/23/1991 SUPPL-10 Labeling

Label is not available on this site.

09/15/1989 SUPPL-9 Labeling

Label is not available on this site.

01/24/1989 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

01/24/1989 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

04/20/1989 SUPPL-3 Bioequivalence

Label is not available on this site.

09/10/1982 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

09/10/1982 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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