Drugs@FDA: FDA-Approved Drugs
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 |
---|---|---|---|---|---|
08/18/2021 | SUPPL-41 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020983s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020983Orig1s041ltr.pdf | |
12/16/2019 | SUPPL-36 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020983s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020983Orig1s036ltr.pdf | |
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-Package Insert, Labeling-Container/Carton Labels |
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 |
---|---|---|---|---|---|
08/18/2021 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020983s041lbl.pdf | |
12/16/2019 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020983s036lbl.pdf | |
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.