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40 | BECLOMETHASONE DIPROPIONATE | 0.04MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | AEROSOL, METERED;INHALATION | Discontinued | None | Yes | No |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80 | BECLOMETHASONE DIPROPIONATE | 0.08MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | AEROSOL, METERED;INHALATION | Discontinued | None | Yes | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 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-30 | Labeling-Patient 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 |