Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017659
Company: BOEHRINGER INGELHEIM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALUPENT METAPROTERENOL SULFATE 5% 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
09/18/1980 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
05/01/1997 SUPPL-34 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/13/1997 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

11/01/1996 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

07/02/1992 SUPPL-30 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/02/1992 SUPPL-29 Labeling

Label is not available on this site.

11/14/1991 SUPPL-26 Labeling

Label is not available on this site.

11/14/1991 SUPPL-25 Efficacy-New Patient Population

Label is not available on this site.

10/29/1986 SUPPL-24 Labeling

Label is not available on this site.

04/12/1988 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

02/14/1986 SUPPL-22 Labeling

Label is not available on this site.

01/31/1986 SUPPL-21 Labeling

Label is not available on this site.

01/31/1986 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

01/31/1986 SUPPL-19 Labeling

Label is not available on this site.

01/31/1986 SUPPL-18 Manufacturing (CMC)-Formulation

Label is not available on this site.

06/19/1985 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

12/30/1983 SUPPL-15 Labeling

Label is not available on this site.

03/03/1983 SUPPL-14 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/05/1982 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/05/1983 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

04/30/1982 SUPPL-10 Labeling

Label is not available on this site.

03/22/1982 SUPPL-9 Labeling

Label is not available on this site.

03/22/1982 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

02/12/1982 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

09/11/1981 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

05/12/1981 SUPPL-5 Labeling

Label is not available on this site.

07/10/1981 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

03/03/1981 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

02/18/1981 SUPPL-2 Labeling

Label is not available on this site.

01/16/1981 SUPPL-1 Labeling

Label is not available on this site.

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