Details for New Drug Application (NDA): 213891
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NDA 213891 describes FROVATRIPTAN SUCCINATE, which is a drug marketed by Amneal Pharms Co, Glenmark Pharms Ltd, Norvium Bioscience, and Renata, and is included in four NDAs. It is available from three suppliers. Additional details are available on the FROVATRIPTAN SUCCINATE profile page.
The generic ingredient in FROVATRIPTAN SUCCINATE is frovatriptan succinate. There are three drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the frovatriptan succinate profile page.
The generic ingredient in FROVATRIPTAN SUCCINATE is frovatriptan succinate. There are three drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the frovatriptan succinate profile page.
Summary for 213891
| Tradename: | FROVATRIPTAN SUCCINATE |
| Applicant: | Renata |
| Ingredient: | frovatriptan succinate |
| Patents: | 0 |
Pharmacology for NDA: 213891
| Mechanism of Action | Serotonin 1b Receptor Agonists Serotonin 1d Receptor Agonists |
Suppliers and Packaging for NDA: 213891
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FROVATRIPTAN SUCCINATE | frovatriptan succinate | TABLET;ORAL | 213891 | ANDA | Ingenus Pharmaceuticals, LLC | 50742-299 | 50742-299-09 | 1 BLISTER PACK in 1 CARTON (50742-299-09) / 9 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 2.5MG BASE | ||||
| Approval Date: | Apr 6, 2022 | TE: | AB | RLD: | No | ||||
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