Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019112
Company: GLAXOSMITHKLINE

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VENTOLIN ALBUTEROL SULFATE EQ 2MG BASE TABLET;ORAL Discontinued None No No
VENTOLIN ALBUTEROL SULFATE EQ 4MG BASE TABLET;ORAL Discontinued None No No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/10/1986 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer 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
09/18/1998 SUPPL-14 Labeling

Label is not available on this site.
10/30/1997 SUPPL-13 Labeling

Label is not available on this site.
01/26/1995 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.
10/13/1992 SUPPL-7 Labeling

Label is not available on this site.
01/28/1992 SUPPL-6 Labeling

Label is not available on this site.
05/25/1989 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.
05/10/1990 SUPPL-4 Labeling

Label is not available on this site.
12/04/1996 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.
12/09/1987 SUPPL-2 Labeling

Label is not available on this site.
06/02/1988 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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