Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020114
Company: MYLAN SPCLT VIATRIS
Company: MYLAN SPCLT VIATRIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ASTELIN | AZELASTINE HYDROCHLORIDE | 0.137MG/SPRAY | SPRAY, METERED;NASAL | Discontinued | None | Yes | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/06/2018 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020114s028lbl.pdf | |
| 10/23/2014 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020114s026lbl.pdf | |
| 01/20/2012 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020114s023lbl.pdf |
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