Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 019773
Company: GLAXOSMITHKLINE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VENTOLIN ALBUTEROL SULFATE EQ 0.083% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SOLUTION;INHALATION Discontinued None Yes No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
04/23/1992 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
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.

06/16/1997 SUPPL-8 Efficacy-New Indication

Label is not available on this site.

01/26/1995 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

04/21/1994 SUPPL-4 Labeling

Label is not available on this site.

11/10/1993 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

01/13/1994 SUPPL-2 Labeling

Label is not available on this site.

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English