Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020626
Company: GLAXOSMITHKLINE
Company: GLAXOSMITHKLINE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| IMITREX | SUMATRIPTAN | 5MG/SPRAY | SPRAY;NASAL | Prescription | AB | Yes | Yes |
| IMITREX | SUMATRIPTAN | 10MG/SPRAY | SPRAY;NASAL | Discontinued | None | No | No |
| IMITREX | SUMATRIPTAN | 20MG/SPRAY | SPRAY;NASAL | Prescription | AB | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/14/2017 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020626s027lbl.pdf | |
| 11/25/2013 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020132s028,020626s025lbl.pdf | |
| 03/01/2012 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020626s018s022lbl.pdf | |
| 07/21/2010 | SUPPL-16 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020626s013s015s016lbl.pdf | |
| 07/21/2010 | SUPPL-15 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020626s013s015s016lbl.pdf | |
| 07/21/2010 | SUPPL-13 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020626s013s015s016lbl.pdf | |
| 10/13/2004 | SUPPL-4 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20626s004lbl.pdf |