Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019269
Company: GLAXOSMITHKLINE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VENTOLIN ALBUTEROL SULFATE EQ 0.5% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SOLUTION;INHALATION Discontinued None No No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
01/16/1987 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-16 Labeling

Label is not available on this site.

10/30/1997 SUPPL-15 Labeling

Label is not available on this site.

06/16/1997 SUPPL-14 Efficacy-New Indication

Label is not available on this site.

01/26/1995 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

07/21/1992 SUPPL-8 Labeling

Label is not available on this site.

08/05/1992 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

07/21/1992 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

07/21/1992 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

03/16/1989 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

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