Details for New Drug Application (NDA): 205394
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NDA 205394 describes RIZAFILM, which is a drug marketed by Gensco and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the RIZAFILM profile page.
The generic ingredient in RIZAFILM is rizatriptan benzoate. There are twenty-two drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the rizatriptan benzoate profile page.
The generic ingredient in RIZAFILM is rizatriptan benzoate. There are twenty-two drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the rizatriptan benzoate profile page.
Summary for 205394
| Tradename: | RIZAFILM |
| Applicant: | Gensco |
| Ingredient: | rizatriptan benzoate |
| Patents: | 1 |
Pharmacology for NDA: 205394
| Mechanism of Action | Serotonin 1b Receptor Agonists Serotonin 1d Receptor Agonists |
Suppliers and Packaging for NDA: 205394
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RIZAFILM | rizatriptan benzoate | FILM;ORAL | 205394 | NDA | Gensco Laboratories LLC | 35781-0600 | 35781-0600-8 | 18 POUCH in 1 CARTON (35781-0600-8) / 1 FILM in 1 POUCH (35781-0600-1) |
| RIZAFILM | rizatriptan benzoate | FILM;ORAL | 205394 | NDA | Gensco Laboratories LLC | 35781-0605 | 35781-0605-8 | 18 POUCH in 1 CARTON (35781-0605-8) / 1 FILM in 1 POUCH (35781-0605-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | FILM;ORAL | Strength | EQ 10MG BASE | ||||
| Approval Date: | Apr 14, 2023 | TE: | RLD: | Yes | |||||
| Patent: | 9,301,948 | Patent Expiration: | Jul 30, 2034 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | FILM;ORAL | Strength | EQ 5MG BASE | ||||
| Approval Date: | Feb 26, 2026 | TE: | RLD: | Yes | |||||
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