Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019621
Company: GLAXOSMITHKLINE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VENTOLIN ALBUTEROL SULFATE EQ 2MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SYRUP;ORAL Discontinued None No No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
06/10/1987 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-10 Labeling

Label is not available on this site.

10/30/1997 SUPPL-9 Labeling

Label is not available on this site.

01/26/1995 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

05/02/1994 SUPPL-5 Labeling

Label is not available on this site.

11/26/1993 SUPPL-4 Labeling

Label is not available on this site.

08/28/1992 SUPPL-3 Labeling

Label is not available on this site.

05/07/1990 SUPPL-2 Labeling

Label is not available on this site.

12/09/1987 SUPPL-1 Labeling

Label is not available on this site.

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