Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019243
Company: SCHERING

Products on NDA 019243

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PROVENTIL	ALBUTEROL SULFATE	EQ 0.5% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	SOLUTION;INHALATION	Discontinued	None	Yes	No
PROVENTIL	ALBUTEROL SULFATE	EQ 0.083% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	SOLUTION;INHALATION	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019243

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/14/1987	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
04/09/2001	SUPPL-22	Manufacturing (CMC)-Control		Label is not available on this site.
04/11/2000	SUPPL-20	Manufacturing (CMC)-Control		Label is not available on this site.
11/06/1998	SUPPL-14	Labeling		Label is not available on this site.
09/09/1996	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
09/07/1993	SUPPL-10	Labeling		Label is not available on this site.
12/15/1992	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
08/26/1992	SUPPL-8	Labeling		Label is not available on this site.
04/22/1992	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
01/19/1993	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
01/24/1989	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
11/21/1988	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.