Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022203
Company: VIATRIS
Company: VIATRIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ASTEPRO | AZELASTINE HYDROCHLORIDE | 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED;NASAL | Discontinued | None | Yes | No |
| ASTEPRO | AZELASTINE HYDROCHLORIDE | 0.2055MG/SPRAY | SPRAY, METERED;NASAL | Discontinued | None | No | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/28/2021 | SUPPL-18 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022203s018lbl.pdf | |
| 06/28/2021 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022203s018lbl.pdf | |
| 09/06/2018 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022203s015lbl.pdf | |
| 02/20/2015 | SUPPL-11 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022203s010s011lbl.pdf | |
| 02/20/2015 | SUPPL-10 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022203s010s011lbl.pdf | |
| 08/30/2013 | SUPPL-8 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022203s008lbl.pdf | |
| 01/19/2011 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022203s006lbl.pdf | |
| 08/31/2009 | SUPPL-3 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022203s003lbl.pdf |