Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019489
Company: GLAXOSMITHKLINE
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
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.

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