Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018761
Company: BOEHRINGER INGELHEIM

Products on NDA 018761

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018761

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.