Details for New Drug Application (NDA): 078739
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NDA 078739 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, Macleods 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 is one drug master file entry for this compound. Twenty-four 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 is one drug master file entry for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the rizatriptan benzoate profile page.
Summary for 078739
| Tradename: | RIZATRIPTAN BENZOATE |
| Applicant: | Chartwell Rx |
| Ingredient: | rizatriptan benzoate |
| Patents: | 0 |
Pharmacology for NDA: 078739
| Mechanism of Action | Serotonin 1b Receptor Agonists Serotonin 1d Receptor Agonists |
Suppliers and Packaging for NDA: 078739
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RIZATRIPTAN BENZOATE | rizatriptan benzoate | TABLET, ORALLY DISINTEGRATING;ORAL | 078739 | ANDA | Chartwell RX, LLC | 62135-998 | 62135-998-17 | 18 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (62135-998-17) |
| RIZATRIPTAN BENZOATE | rizatriptan benzoate | TABLET, ORALLY DISINTEGRATING;ORAL | 078739 | ANDA | Chartwell RX, LLC | 62135-999 | 62135-999-17 | 18 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (62135-999-17) |
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 | |||||
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