Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021912
Company: LUPIN
Company: LUPIN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BROVANA | ARFORMOTEROL TARTRATE | EQ 0.015MG BASE/2ML | SOLUTION;INHALATION | Prescription | AN | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/29/2019 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021912Orig1s032lblrpl.pdf | |
| 02/27/2014 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021912s013lbl.pdf | |
| 02/27/2014 | SUPPL-23 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021912s013lbl.pdf | |
| 07/14/2011 | SUPPL-6 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021912s006lbl.pdf | |
| 02/16/2011 | SUPPL-15 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021912s015lbl.pdf | |
| 02/16/2011 | SUPPL-15 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021912s015lbl.pdf | |
| 06/02/2010 | SUPPL-11 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021912s011lbl.pdf | |
| 12/20/2007 | SUPPL-1 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021912s001lbl.pdf | |
| 10/06/2006 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021912lbl.pdf |