Details for New Drug Application (NDA): 213465
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NDA 213465 describes SUMATRIPTAN, which is a drug marketed by Adaptis, Cipla, Lannett Co Inc, Padagis Israel, Aurobindo Pharma Ltd, Rising, Sun Pharm, Antares Pharma Inc, Baxter Hlthcare Corp, Caplin, Dr Reddys, Endo Operations, Eugia Pharma, Fresenius Kabi Usa, Hikma, Norvium Bioscience, Sandoz, Steriscience Speclts, Teva Parenteral, Teva Pharms Usa, West-ward Pharms Int, Wockhardt, Zydus, Aurobindo Pharma, Corepharma, Dr Reddys Labs Inc, Fosun Pharma, Hikma Pharms, Mylan, Orbion Pharms, Roxane, Sun Pharm Inds, Sun Pharm Inds Ltd, Teva, and Watson Labs, and is included in forty-one NDAs. It is available from six suppliers. Additional details are available on the SUMATRIPTAN profile page.
The generic ingredient in SUMATRIPTAN is sumatriptan succinate. There are twenty-four drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the sumatriptan succinate profile page.
The generic ingredient in SUMATRIPTAN is sumatriptan succinate. There are twenty-four drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the sumatriptan succinate profile page.
Summary for 213465
| Tradename: | SUMATRIPTAN |
| Applicant: | Padagis Israel |
| Ingredient: | sumatriptan |
| Patents: | 0 |
Pharmacology for NDA: 213465
| Mechanism of Action | Serotonin 1b Receptor Agonists Serotonin 1d Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 213465
Suppliers and Packaging for NDA: 213465
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SUMATRIPTAN | sumatriptan | SPRAY;NASAL | 213465 | ANDA | Padagis Israel Pharmaceuticals Ltd | 45802-598 | 45802-598-06 | 6 CONTAINER in 1 CARTON (45802-598-06) / 1 SPRAY in 1 CONTAINER (45802-598-00) |
| SUMATRIPTAN | sumatriptan | SPRAY;NASAL | 213465 | ANDA | Padagis Israel Pharmaceuticals Ltd | 45802-619 | 45802-619-06 | 6 CONTAINER in 1 CARTON (45802-619-06) / 1 SPRAY in 1 CONTAINER (45802-619-00) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SPRAY;NASAL | Strength | 20MG/SPRAY | ||||
| Approval Date: | Sep 21, 2020 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SPRAY;NASAL | Strength | 5MG/SPRAY | ||||
| Approval Date: | Sep 21, 2020 | TE: | AB | RLD: | No | ||||
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