Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016402
Company: BOEHRINGER INGELHEIM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALUPENT METAPROTERENOL SULFATE 0.65MG/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
07/31/1973 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/26/1997 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

07/16/1997 SUPPL-35 Labeling

Label is not available on this site.

07/08/1994 SUPPL-34 Labeling

Label is not available on this site.

12/07/1989 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

03/17/1989 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

03/17/1989 SUPPL-29 Labeling

Label is not available on this site.

03/17/1989 SUPPL-28 Manufacturing (CMC)-Formulation

Label is not available on this site.

07/24/1986 SUPPL-27 Labeling

Label is not available on this site.

10/09/1986 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

06/04/1986 SUPPL-25 Labeling

Label is not available on this site.

11/29/1985 SUPPL-23 Labeling

Label is not available on this site.

05/17/1985 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

08/21/1984 SUPPL-21 Labeling

Label is not available on this site.

08/16/1984 SUPPL-20 Labeling

Label is not available on this site.

08/16/1984 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

04/01/1982 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

04/01/1982 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

06/24/1981 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

01/04/1980 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/01/1979 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

10/13/1978 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

10/20/1978 SUPPL-12 Labeling

Label is not available on this site.

05/25/1977 SUPPL-11 Labeling

Label is not available on this site.

12/22/1976 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

12/22/1976 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

10/07/1976 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/18/1974 SUPPL-6 Labeling

Label is not available on this site.

12/18/1974 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

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