Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019489
Company: GLAXOSMITHKLINE

Products on NDA 019489

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VENTOLIN ROTACAPS	ALBUTEROL SULFATE	EQ 0.2MG BASE	CAPSULE;INHALATION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019489

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/04/1988	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
06/30/1999	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
07/30/1998	SUPPL-18	Labeling		Label is not available on this site.
12/26/1996	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
01/26/1995	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
06/14/1994	SUPPL-12	Labeling		Label is not available on this site.
01/27/1994	SUPPL-11	Labeling		Label is not available on this site.
08/18/1993	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
07/20/1993	SUPPL-8	Efficacy-New Patient Population		Label is not available on this site.
10/28/1992	SUPPL-7	Labeling		Label is not available on this site.
05/21/1992	SUPPL-6	Labeling		Label is not available on this site.
04/06/1992	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
12/15/1992	SUPPL-3	Manufacturing (CMC)-Packaging		Label is not available on this site.
09/24/1990	SUPPL-2	Labeling		Label is not available on this site.
09/24/1990	SUPPL-1	Efficacy-New Patient Population		Label is not available on this site.