Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 015874
Company: BOEHRINGER INGELHEIM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALUPENT METAPROTERENOL SULFATE 20MG TABLET;ORAL Discontinued None No No
ALUPENT METAPROTERENOL SULFATE 10MG TABLET;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
05/13/1974 ORIG-1 Approval Type 3 - New Dosage Form 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
03/11/1991 SUPPL-36 Labeling

Label is not available on this site.

04/28/1992 SUPPL-35 Labeling

Label is not available on this site.

02/14/1986 SUPPL-34 Labeling

Label is not available on this site.

05/04/1984 SUPPL-33 Labeling

Label is not available on this site.

12/10/1985 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

11/10/1983 SUPPL-31 Labeling

Label is not available on this site.

12/10/1985 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

01/05/1983 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

05/05/1983 SUPPL-28 Labeling

Label is not available on this site.

05/05/1983 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

02/12/1982 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

06/24/1981 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

04/07/1981 SUPPL-23 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/11/1980 SUPPL-22 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/09/1980 SUPPL-21 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/26/1979 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

06/28/1978 SUPPL-19 Labeling

Label is not available on this site.

08/08/1977 SUPPL-18 Labeling

Label is not available on this site.

05/05/1980 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

10/29/1976 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

12/08/1976 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/12/1976 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

11/12/1976 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

08/08/1977 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

07/20/1976 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

07/20/1976 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

04/26/1976 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

07/19/1976 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/11/1976 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

09/23/1976 SUPPL-6 Labeling

Label is not available on this site.

12/19/1974 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

12/19/1974 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

12/19/1974 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

12/19/1974 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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