Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 016402
Company: BOEHRINGER INGELHEIM

Products on NDA 016402

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 016402

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.