Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021450
Company: AMNEAL
Company: AMNEAL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ZOMIG | ZOLMITRIPTAN | 2.5MG/SPRAY | SPRAY;NASAL | Prescription | AB | Yes | Yes |
| ZOMIG | ZOLMITRIPTAN | 5MG/SPRAY | SPRAY;NASAL | Prescription | AB | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/21/2018 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020768s023,021231s014,021450s010lbl.pdf | |
| 06/12/2015 | SUPPL-8 | Efficacy-Pediatric | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021450s008lbl.pdf | |
| 09/16/2013 | SUPPL-7 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021450s007lbl.pdf | |
| 09/30/2003 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21450_zomig_lbl.pdf |