Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018761
Company: BOEHRINGER INGELHEIM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALUPENT METAPROTERENOL SULFATE 0.6% SOLUTION;INHALATION Discontinued None No No
ALUPENT METAPROTERENOL SULFATE 0.4% 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
06/30/1983 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
01/23/2002 SUPPL-16 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18761s16ltr.pdf
12/02/1997 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

10/27/1998 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

08/22/1990 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

03/14/1990 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

12/22/1987 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

07/10/1986 SUPPL-7 Labeling

Label is not available on this site.

10/10/1986 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

10/10/1986 SUPPL-5 Labeling

Label is not available on this site.

10/10/1986 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

10/17/1985 SUPPL-3 Labeling

Label is not available on this site.

03/02/1985 SUPPL-2 Labeling

Label is not available on this site.

03/02/1985 SUPPL-1 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

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