Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 088226
Company: ROXANE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ISOETHARINE HYDROCHLORIDE ISOETHARINE HYDROCHLORIDE 0.167% 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
09/16/1983 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
08/28/1996 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

03/15/1991 SUPPL-8 Labeling

Label is not available on this site.

01/27/1992 SUPPL-7 Labeling

Label is not available on this site.

03/22/1990 SUPPL-6 Labeling

Label is not available on this site.

01/24/1989 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

01/24/1989 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

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