Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017571
Company: BOEHRINGER INGELHEIM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALUPENT METAPROTERENOL SULFATE 10MG/5ML SYRUP;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
05/23/1975 ORIG-1 Approval Type 3 - New Dosage Form 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
10/15/1991 SUPPL-32 Labeling

Label is not available on this site.

04/29/1992 SUPPL-30 Labeling

Label is not available on this site.

10/29/1986 SUPPL-28 Labeling

Label is not available on this site.

06/05/1986 SUPPL-27 Labeling

Label is not available on this site.

06/05/1986 SUPPL-26 Manufacturing (CMC)-Formulation

Label is not available on this site.

05/28/1985 SUPPL-24 Labeling

Label is not available on this site.

05/28/1985 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

06/20/1985 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

05/04/1984 SUPPL-21 Labeling

Label is not available on this site.

06/20/1985 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

11/10/1983 SUPPL-19 Labeling

Label is not available on this site.

01/05/1983 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

03/22/1982 SUPPL-17 Labeling

Label is not available on this site.

03/22/1982 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

02/12/1982 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

07/08/1982 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

06/24/1981 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

08/11/1981 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/14/1980 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/25/1979 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

04/03/1979 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/01/1976 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

11/01/1976 SUPPL-5 Labeling

Label is not available on this site.

11/01/1976 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

11/01/1976 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

12/08/1975 SUPPL-1 Labeling

Label is not available on this site.

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