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 |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 10/06/2006 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021912lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021912s000tr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021912_brovana_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021912s000_SumR.pdf |
Supplements
| 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)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021912Orig1s032lblrpl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021912Orig1s032ltr.pdf | |
| 12/12/2016 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/11/2016 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/06/2015 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/16/2015 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/11/2015 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/25/2014 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/27/2014 | SUPPL-23 | Efficacy-Labeling Change With Clinical Data, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021912s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021912Orig1s023ltr.pdf | |
| 02/26/2013 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/14/2013 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/09/2012 | SUPPL-20 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021912Orig1s018,s020ltr.pdf |
| 08/09/2012 | SUPPL-18 |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021912Orig1s018,s020ltr.pdf | |
| 09/02/2011 | SUPPL-16 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021912s016ltr.pdf |
| 02/16/2011 | SUPPL-15 | Labeling, REMS-Modified |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021912s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021912s015ltr.pdf | |
| 02/01/2011 | SUPPL-12 | REMS-Proposal |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021912s012ltr.pdf |
| 06/02/2010 | SUPPL-11 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021912s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021912s011ltr.pdf | |
| 06/22/2010 | SUPPL-8 | Labeling-Medication Guide |
Label is not available on this site. |
||
| 07/14/2011 | SUPPL-6 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021912s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021912s006ltr.pdf | |
| 12/20/2007 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021912s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021912s001ltr.pdf |
| 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 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021912s013lbl.pdf | |
| 02/27/2014 | SUPPL-23 | Labeling-Package Insert | 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 |
BROVANA
SOLUTION;INHALATION; EQ 0.015MG BASE/2ML
TE Code = AN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ARFORMOTEROL TARTRATE | ARFORMOTEROL TARTRATE | EQ 0.015MG BASE/2ML | SOLUTION;INHALATION | Prescription | No | AN | 214779 | ALEMBIC |
| ARFORMOTEROL TARTRATE | ARFORMOTEROL TARTRATE | EQ 0.015MG BASE/2ML | SOLUTION;INHALATION | Prescription | No | AN | 216303 | CF PHARMTECH |
| ARFORMOTEROL TARTRATE | ARFORMOTEROL TARTRATE | EQ 0.015MG BASE/2ML | SOLUTION;INHALATION | Prescription | No | AN | 207306 | CIPLA |
| ARFORMOTEROL TARTRATE | ARFORMOTEROL TARTRATE | EQ 0.015MG BASE/2ML | SOLUTION;INHALATION | Prescription | No | AN | 215032 | DR REDDYS |
| ARFORMOTEROL TARTRATE | ARFORMOTEROL TARTRATE | EQ 0.015MG BASE/2ML | SOLUTION;INHALATION | Prescription | No | AN | 213068 | LUPIN |
| ARFORMOTEROL TARTRATE | ARFORMOTEROL TARTRATE | EQ 0.015MG BASE/2ML | SOLUTION;INHALATION | Prescription | No | AN | 216128 | MANKIND PHARMA |
| ARFORMOTEROL TARTRATE | ARFORMOTEROL TARTRATE | EQ 0.015MG BASE/2ML | SOLUTION;INHALATION | Prescription | No | AN | 214901 | PHARMAMAX |
| ARFORMOTEROL TARTRATE | ARFORMOTEROL TARTRATE | EQ 0.015MG BASE/2ML | SOLUTION;INHALATION | Prescription | No | AN | 214736 | RITEDOSE CORP |
| ARFORMOTEROL TARTRATE | ARFORMOTEROL TARTRATE | EQ 0.015MG BASE/2ML | SOLUTION;INHALATION | Prescription | No | AN | 213762 | SLATE RUN PHARMA |
| ARFORMOTEROL TARTRATE | ARFORMOTEROL TARTRATE | EQ 0.015MG BASE/2ML | SOLUTION;INHALATION | Prescription | No | AN | 216815 | SLAYBACK PHARMA LLC |
| ARFORMOTEROL TARTRATE | ARFORMOTEROL TARTRATE | EQ 0.015MG BASE/2ML | SOLUTION;INHALATION | Prescription | No | AN | 215385 | SUN PHARM |
| ARFORMOTEROL TARTRATE | ARFORMOTEROL TARTRATE | EQ 0.015MG BASE/2ML | SOLUTION;INHALATION | Prescription | No | AN | 200293 | TEVA PHARMS USA |
| BROVANA | ARFORMOTEROL TARTRATE | EQ 0.015MG BASE/2ML | SOLUTION;INHALATION | Prescription | Yes | AN | 021912 | LUPIN |