Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 015874
Company: BOEHRINGER INGELHEIM

Products on NDA 015874

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 015874

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
11/12/2002	SUPPL-37	Labeling		Label is not available on this site.
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.
11/12/2002	SUPPL-24	Labeling		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.