Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021457
Company: TEVA BRANDED PHARM
Company: TEVA BRANDED PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROAIR HFA | ALBUTEROL SULFATE | EQ 0.09MG BASE/INH | AEROSOL, METERED;INHALATION | Prescription | AB2 | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/25/2019 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021457s036lbl.pdf | |
| 03/07/2012 | SUPPL-26 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021457s026lbl.pdf |
| 08/17/2010 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021457s021lbl.pdf | |
| 09/16/2008 | SUPPL-13 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021457s013lbl.pdf | |
| 02/03/2006 | SUPPL-3 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021457s003lbl.pdf | |
| 11/21/2005 | SUPPL-4 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021457s002,004lbl.pdf | |
| 11/21/2005 | SUPPL-2 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021457s002,004lbl.pdf | |
| 05/02/2005 | SUPPL-1 | Manufacturing (CMC)-Control | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021457s001lbl.pdf |
| 10/29/2004 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21457lbl.pdf |