Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 205636
Company: TEVA BRANDED PHARM
Company: TEVA BRANDED PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROAIR DIGIHALER | ALBUTEROL SULFATE | EQ 0.09MG BASE/INH | POWDER, METERED;INHALATION | Discontinued | None | Yes | No |
| PROAIR RESPICLICK | ALBUTEROL SULFATE | EQ 0.09MG BASE/INH | POWDER, METERED;INHALATION | Prescription | None | 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 |
|---|---|---|---|---|---|---|---|
| 06/14/1996 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205636s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205636Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205636Orig1s000TAltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205636Orig1s000TOC.html https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205636Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/07/2025 | SUPPL-214 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/21/2023 | SUPPL-202 | Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 11/15/2019 | SUPPL-199 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/15/2019 | SUPPL-198 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 11/15/2019 | SUPPL-196 | Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 08/13/2019 | SUPPL-195 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 11/01/2018 | SUPPL-191 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/11/2018 | SUPPL-190 | Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 06/06/2017 | SUPPL-176 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 01/06/2017 | SUPPL-172 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/12/2015 | SUPPL-163 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/10/2015 | SUPPL-161 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/11/2015 | SUPPL-159 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/25/2015 | SUPPL-157 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 01/26/2015 | SUPPL-156 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/11/2014 | SUPPL-155 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/12/2014 | SUPPL-152 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/04/2014 | SUPPL-150 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/11/2014 | SUPPL-149 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/03/2014 | SUPPL-148 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/01/2014 | SUPPL-147 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/24/2014 | SUPPL-146 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/18/2014 | SUPPL-145 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/04/2014 | SUPPL-144 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/31/2014 | SUPPL-143 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/15/2013 | SUPPL-142 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/18/2013 | SUPPL-141 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/21/2013 | SUPPL-139 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/28/2013 | SUPPL-137 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/14/2013 | SUPPL-135 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/10/2013 | SUPPL-134 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/06/2013 | SUPPL-133 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/15/2013 | SUPPL-132 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/12/2013 | SUPPL-131 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/30/2013 | SUPPL-127 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/13/2015 | SUPPL-124 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/14/2012 | SUPPL-123 | Efficacy-New Route Of Administration |
Label is not available on this site. |
||
| 10/30/2011 | SUPPL-117 | Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 03/11/2013 | SUPPL-115 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 05/18/2011 | SUPPL-105 | Efficacy-New Patient Population |
Label is not available on this site. |
||
| 05/18/2011 | SUPPL-98 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/16/2009 | SUPPL-91 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/22/2007 | SUPPL-82 | Labeling |
Label is not available on this site. |
||
| 06/14/2007 | SUPPL-76 | Labeling |
Label is not available on this site. |
||
| 09/06/2007 | SUPPL-75 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/22/2007 | SUPPL-65 | Labeling |
Label is not available on this site. |
||
| 09/07/2007 | SUPPL-64 | Labeling |
Label is not available on this site. |
||
| 11/09/2005 | SUPPL-60 | Labeling |
Label is not available on this site. |
||
| 05/20/2005 | SUPPL-54 | Labeling |
Label is not available on this site. |
||
| 07/31/2014 | SUPPL-51 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/21/2004 | SUPPL-46 | Labeling |
Label is not available on this site. |
||
| 11/19/2003 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/29/2003 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/24/2003 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 01/16/2004 | SUPPL-36 | Labeling |
Label is not available on this site. |
||
| 10/25/2002 | SUPPL-35 | Efficacy-New Indication |
Label is not available on this site. |
||
| 02/05/2002 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/17/2001 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/01/2003 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 05/11/2001 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/26/2001 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/11/2000 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/12/2003 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 07/07/2000 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/14/2000 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/02/2004 | SUPPL-24 | Efficacy-New Route Of Administration |
Label is not available on this site. |
||
| 05/23/2000 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/25/2000 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/11/2000 | SUPPL-20 | Manufacturing (CMC) |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205636s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/205636Orig1s020ltr.pdf | |
| 05/12/1999 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/02/2003 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 02/25/1999 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/25/1999 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/04/2000 | SUPPL-13 | Efficacy-Labeling Change With Clinical Data |
Label is not available on this site. |
||
| 04/04/2000 | SUPPL-12 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205636Orig1s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/205636Orig1s012ltr.pdf | |
| 04/04/2000 | SUPPL-11 | Efficacy-Labeling Change With Clinical Data |
Label is not available on this site. |
||
| 04/04/2000 | SUPPL-10 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
||
| 09/04/1998 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/06/1998 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205636s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205636Orig1s006ltr.pdf | |
| 04/29/1997 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/20/1998 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205636s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205636Orig1s004ltr.pdf | |
| 07/16/1997 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 03/05/1997 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/09/1997 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/07/2025 | SUPPL-214 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020563s214,205747s038lbl.pdf | |
| 07/21/2023 | SUPPL-202 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020563Orig1s202,205747Orig1s028Lbl.pdf | |
| 07/21/2023 | SUPPL-202 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020563Orig1s202,205747Orig1s028Lbl.pdf | |
| 07/21/2023 | SUPPL-202 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020563Orig1s202,205747Orig1s028Lbl.pdf | |
| 11/15/2019 | SUPPL-199 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020563s196s198s199,205747s022s025s026lbl.pdf | |
| 11/15/2019 | SUPPL-198 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020563s196s198s199,205747s022s025s026lbl.pdf | |
| 11/15/2019 | SUPPL-198 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020563s196s198s199,205747s022s025s026lbl.pdf | |
| 11/15/2019 | SUPPL-196 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020563s196s198s199,205747s022s025s026lbl.pdf | |
| 11/15/2019 | SUPPL-196 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020563s196s198s199,205747s022s025s026lbl.pdf | |
| 11/15/2019 | SUPPL-196 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020563s196s198s199,205747s022s025s026lbl.pdf | |
| 08/13/2019 | SUPPL-195 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020563s195,205747s021lbl.pdf | |
| 08/13/2019 | SUPPL-195 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020563s195,205747s021lbl.pdf | |
| 12/11/2018 | SUPPL-190 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020563s190lbl.pdf | |
| 12/11/2018 | SUPPL-190 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020563s190lbl.pdf | |
| 12/11/2018 | SUPPL-190 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020563s190lbl.pdf | |
| 11/01/2018 | SUPPL-191 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020563s191,205747s018lbl.pdf | |
| 06/06/2017 | SUPPL-176 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020563s176lbl.pdf | |
| 06/06/2017 | SUPPL-176 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020563s176lbl.pdf | |
| 01/06/2017 | SUPPL-172 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020563Orig1s172,205747Orig1s008ltr.pdf | |
| 06/12/2015 | SUPPL-163 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020563s163lbl.pdf | |
| 03/13/2015 | SUPPL-124 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020563s124lbl.pdf | |
| 02/25/2015 | SUPPL-157 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020563s157lbl.pdf | |
| 03/11/2013 | SUPPL-115 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020563s115lbl.pdf | |
| 03/11/2013 | SUPPL-115 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020563s115lbl.pdf | |
| 01/30/2013 | SUPPL-127 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020563s127lbl.pdf | |
| 10/14/2012 | SUPPL-123 | Efficacy-New Route Of Administration | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020563s123lbl.pdf | |
| 10/30/2011 | SUPPL-117 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020563s117lbl.pdf | |
| 05/18/2011 | SUPPL-105 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020563s098s105lbl.pdf | |
| 05/18/2011 | SUPPL-98 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020563s098s105lbl.pdf | |
| 03/16/2009 | SUPPL-91 | Manufacturing (CMC)-Control | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018781s108,020563s091,021017s053,021018s049lbl.pdf |
| 09/06/2007 | SUPPL-75 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020563s075,021017s040,021018s034lbl.pdf | |
| 08/22/2007 | SUPPL-65 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020563s065,021017s030,021018s041lbl.pdf | |
| 07/22/2007 | SUPPL-82 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020563s082lbl.pdf | |
| 06/14/2007 | SUPPL-76 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020563s076lbl.pdf | |
| 05/20/2005 | SUPPL-54 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020563s054lbl.pdf | |
| 06/02/2004 | SUPPL-24 | Efficacy-New Route Of Administration | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20563se3-024_humalog_lbl.pdf | |
| 04/21/2004 | SUPPL-46 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20563slr046_humalog_lbl.pdf | |
| 01/16/2004 | SUPPL-36 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20563slr036_humalog_lbl.pdf | |
| 11/19/2003 | SUPPL-44 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20563scm044_humalog_lbl.pdf |
| 09/29/2003 | SUPPL-41 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020563s041lbl.pdf |
| 06/24/2003 | SUPPL-40 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20563slr040_humalog_lbl.pdf | |
| 04/01/2003 | SUPPL-32 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020563s032lbl.pdf | |
| 02/12/2003 | SUPPL-27 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020563s027lbl.pdf | |
| 04/04/2000 | SUPPL-13 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20563S10-11-12-13LBL.PDF | |
| 04/04/2000 | SUPPL-12 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20563S10-11-12-13LBL.PDF | |
| 04/04/2000 | SUPPL-11 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20563S10-11-12-13LBL.PDF | |
| 04/04/2000 | SUPPL-10 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20563S10-11-12-13LBL.PDF | |
| 02/25/1999 | SUPPL-15 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20563slr015_humalog_lbl.pdf |