Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 013296
Company: 3M
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DUO-MEDIHALER ISOPROTERENOL HYDROCHLORIDE; PHENYLEPHRINE BITARTRATE 0.16MG/INH;0.24MG/INH AEROSOL, METERED;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
08/20/1973 ORIG-1 Approval Type 4 - New Combination STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/23/1994 SUPPL-13 Labeling

Label is not available on this site.

02/27/1987 SUPPL-11 Labeling

Label is not available on this site.

05/21/1984 SUPPL-10 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/05/1982 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

03/13/2009 SUPPL-8 Labeling

Label is not available on this site.

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