Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018473
Company: GLAXOSMITHKLINE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VENTOLIN ALBUTEROL 0.09MG/INH AEROSOL, METERED;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
05/01/1981 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer PRIORITY Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18473slr030ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/25/2001 SUPPL-31 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

06/20/2003 SUPPL-30 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18473slr030ltr.pdf
08/31/1998 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

07/30/1998 SUPPL-28 Labeling

Label is not available on this site.

11/12/1997 SUPPL-27 Labeling

Label is not available on this site.

01/26/1995 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

02/02/1994 SUPPL-22 Labeling

Label is not available on this site.

07/20/1993 SUPPL-21 Efficacy-New Patient Population

Label is not available on this site.

10/09/1992 SUPPL-20 Labeling

Label is not available on this site.

11/22/1991 SUPPL-19 Labeling

Label is not available on this site.

04/14/1989 SUPPL-17 Labeling

Label is not available on this site.

09/24/1990 SUPPL-15 Efficacy-New Patient Population

Label is not available on this site.

07/27/1987 SUPPL-14 Labeling

Label is not available on this site.

07/27/1987 SUPPL-13 Labeling

Label is not available on this site.

11/22/1985 SUPPL-11 Labeling

Label is not available on this site.

03/20/1985 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

07/22/1985 SUPPL-8 Labeling

Label is not available on this site.

07/22/1985 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

02/06/1985 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

09/15/1984 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

04/21/1983 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

08/09/1982 SUPPL-2 Labeling

Label is not available on this site.

08/09/1982 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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