Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018062
Company: SCHERING

Products on NDA 018062

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PROVENTIL	ALBUTEROL SULFATE	EQ 2MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	SYRUP;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018062

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/19/1983	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
08/12/1999	SUPPL-19	Manufacturing (CMC)-Control		Label is not available on this site.
08/18/1998	SUPPL-18	Manufacturing (CMC)-Control		Label is not available on this site.
11/06/1998	SUPPL-16	Labeling		Label is not available on this site.
09/09/1996	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
05/27/1993	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
01/24/1989	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
11/19/1986	SUPPL-7	Manufacturing (CMC)-Packaging		Label is not available on this site.
07/08/1986	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
12/04/1984	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
04/12/1985	SUPPL-4	Efficacy		Label is not available on this site.
05/16/1985	SUPPL-2	Labeling		Label is not available on this site.
05/16/1985	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.