Details for New Drug Application (NDA): 213465
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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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