Details for New Drug Application (NDA): 203478
✉ Email this page to a colleague
NDA 203478 describes RIZATRIPTAN BENZOATE, which is a drug marketed by Apotex Inc, Aurobindo Pharma Ltd, Chartwell Rx, Glenmark Pharms Ltd, Jubilant Generics, Macleods Pharms Ltd, Natco Pharma Ltd, Panacea, Pharmobedient, Unichem, Alkem Labs Ltd, Avet Lifesciences, Creekwood Pharms, Invagen Pharms, Sandoz, and Teva Pharms, and is included in twenty-five NDAs. It is available from twenty-two suppliers. Additional details are available on the RIZATRIPTAN BENZOATE profile page.
The generic ingredient in RIZATRIPTAN BENZOATE 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 RIZATRIPTAN BENZOATE 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 203478
| Tradename: | RIZATRIPTAN BENZOATE |
| Applicant: | Natco Pharma Ltd |
| Ingredient: | rizatriptan benzoate |
| Patents: | 0 |
Pharmacology for NDA: 203478
| Mechanism of Action | Serotonin 1b Receptor Agonists Serotonin 1d Receptor Agonists |
Suppliers and Packaging for NDA: 203478
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RIZATRIPTAN BENZOATE | rizatriptan benzoate | TABLET, ORALLY DISINTEGRATING;ORAL | 203478 | ANDA | Proficient Rx LP | 63187-563 | 63187-563-06 | 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63187-563-06) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | EQ 5MG BASE | ||||
| Approval Date: | Jul 1, 2013 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | EQ 10MG BASE | ||||
| Approval Date: | Jul 1, 2013 | TE: | RLD: | No | |||||
Complete Access Available with Subscription
