Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020911
Company: TEVA BRANDED PHARM
Company: TEVA BRANDED PHARM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
QVAR 40 | BECLOMETHASONE DIPROPIONATE | 0.04MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | AEROSOL, METERED;INHALATION | Discontinued | None | Yes | No |
QVAR 80 | BECLOMETHASONE DIPROPIONATE | 0.08MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | AEROSOL, METERED;INHALATION | Discontinued | None | Yes | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
09/15/2000 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-911_QVAR_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-911_QVAR_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-911_Qvar.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/29/2017 | SUPPL-30 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020911s029s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020911Orig1s029,s030ltr.pdf | |
09/29/2017 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020911s029s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020911Orig1s029,s030ltr.pdf | |
12/16/2015 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/22/2014 | SUPPL-26 | Manufacturing (CMC) |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020911s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020911Origs026ltr.pdf | |
07/21/2014 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020911s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020911Orig1s025ltr.pdf | |
03/09/2015 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/08/2013 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/30/2012 | SUPPL-22 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020911s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020911Orig1s022ltr.pdf | |
08/18/2008 | SUPPL-17 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020911s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020911s017ltr.pdf | |
11/20/2006 | SUPPL-15 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020911s015_LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020911s015_ltr.pdf | |
08/01/2003 | SUPPL-8 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20911slr008ltr.pdf |
07/11/2002 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
01/17/2002 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
05/10/2002 | SUPPL-5 | Efficacy-New Patient Population |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20911s005ltr.pdf |
08/02/2001 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/17/2001 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/27/2001 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
02/01/2001 | 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 |
---|---|---|---|---|---|
09/29/2017 | SUPPL-30 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020911s029s030lbl.pdf | |
09/29/2017 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020911s029s030lbl.pdf | |
09/29/2017 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020911s029s030lbl.pdf | |
07/21/2014 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020911s025lbl.pdf | |
05/22/2014 | SUPPL-26 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020911s026lbl.pdf |
07/30/2012 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020911s022lbl.pdf | |
08/18/2008 | SUPPL-17 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020911s017lbl.pdf | |
11/20/2006 | SUPPL-15 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020911s015_LBL.pdf | |
09/15/2000 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-911_QVAR_Prntlbl.pdf |