Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020503
Company: KINDEVA
Company: KINDEVA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROVENTIL-HFA | ALBUTEROL SULFATE | EQ 0.09MG BASE/INH | AEROSOL, METERED;INHALATION | Prescription | AB1 | 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 |
|---|---|---|---|---|---|---|---|
| 08/15/1996 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/22/2017 | SUPPL-54 | Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020503s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020503Orig1s054ltr.pdf | |
| 11/09/2016 | SUPPL-53 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/03/2016 | SUPPL-51 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/12/2016 | SUPPL-50 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/03/2015 | SUPPL-49 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/25/2013 | SUPPL-47 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/020503Orig1s047.pdf |
| 06/05/2012 | SUPPL-46 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020503s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020503s046ltr.pdf | |
| 09/08/2009 | SUPPL-39 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020503s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020503s039ltr.pdf | |
| 01/29/2004 | SUPPL-22 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20503slr022ltr.pdf |
| 07/26/2002 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/17/2002 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/17/2001 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/10/2002 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/05/2000 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/28/2000 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/18/2002 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/16/2000 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/13/2000 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/12/2000 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/02/1999 | SUPPL-11 | Efficacy-New Indication |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20503s11ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20503-S011_Proventil.pdf |
| 08/18/1999 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/04/2000 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/17/1999 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/12/1998 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/16/2000 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/05/1998 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/23/1998 | SUPPL-4 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20503s4lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20503s4ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20503-S004_Proventil.pdf | |
| 08/18/1997 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/22/1997 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 12/26/1996 | 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 |
|---|---|---|---|---|---|
| 09/22/2017 | SUPPL-54 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020503s054lbl.pdf | |
| 06/05/2012 | SUPPL-46 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020503s046lbl.pdf | |
| 09/08/2009 | SUPPL-39 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020503s039lbl.pdf | |
| 09/23/1998 | SUPPL-4 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20503s4lbl.pdf |
PROVENTIL-HFA
AEROSOL, METERED;INHALATION; EQ 0.09MG BASE/INH
TE Code = AB1
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ALBUTEROL SULFATE | ALBUTEROL SULFATE | EQ 0.09MG BASE/INH | AEROSOL, METERED;INHALATION | Prescription | No | AB1 | 209959 | CIPLA |
| ALBUTEROL SULFATE | ALBUTEROL SULFATE | EQ 0.09MG BASE/INH | AEROSOL, METERED;INHALATION | Prescription | No | AB1 | 207085 | SANDOZ |
| PROVENTIL-HFA | ALBUTEROL SULFATE | EQ 0.09MG BASE/INH | AEROSOL, METERED;INHALATION | Prescription | Yes | AB1 | 020503 | KINDEVA |