Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020983
Company: GLAXOSMITHKLINE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VENTOLIN HFA ALBUTEROL SULFATE EQ 0.09MG BASE/INH AEROSOL, METERED;INHALATION Prescription BX Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/19/2001 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20983lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20983ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-983_Ventolin-HFA.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/14/2015 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

01/12/2015 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

12/19/2014 SUPPL-32 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020983s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020983Orig1s032ltr.pdf
06/17/2014 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

01/03/2014 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

01/21/2014 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

09/06/2012 SUPPL-27 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020983s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020983Orig1s027ltr.pdf
03/26/2008 SUPPL-16 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020983s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020983s016ltr.pdf
08/27/2008 SUPPL-13

Label is not available on this site.

03/17/2006 SUPPL-10 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

04/19/2005 SUPPL-9 Manufacturing (CMC)-Control Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020983s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020983s009ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020983Orig1s009Approv.pdf
09/10/2002 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

03/04/2002 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

10/25/2001 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

07/09/2001 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/19/2014 SUPPL-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020983s032lbl.pdf
09/06/2012 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020983s027lbl.pdf
03/26/2008 SUPPL-16 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020983s016lbl.pdf
04/19/2005 SUPPL-9 Manufacturing (CMC)-Control Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020983s009lbl.pdf
04/19/2001 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20983lbl.pdf

VENTOLIN HFA

There are no Therapeutic Equivalents.

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