Details for New Drug Application (NDA): 203478
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NDA 203478 describes RIZATRIPTAN BENZOATE, which is a drug marketed by Apotex Inc, Aurobindo Pharma Ltd, Glenmark Pharms Ltd, Jubilant Generics, Macleods Pharms Ltd, Natco Pharma Ltd, Norvium Bioscience, Panacea, Sandoz, Unichem, Alkem Labs Ltd, Avet Lifesciences, Chartwell Rx, Creekwood Pharms, Invagen Pharms, Mylan Pharms Inc, 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-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 are twenty-two drug master file entries for this compound. Twenty-four 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 | Breckenridge Pharmaceutical, Inc. | 51991-362 | 51991-362-78 | 3 BLISTER PACK in 1 CARTON (51991-362-78) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (51991-362-99) |
| RIZATRIPTAN BENZOATE | rizatriptan benzoate | TABLET, ORALLY DISINTEGRATING;ORAL | 203478 | ANDA | Breckenridge Pharmaceutical, Inc. | 51991-363 | 51991-363-78 | 3 BLISTER PACK in 1 CARTON (51991-363-78) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (51991-363-99) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | EQ 5MG BASE | ||||
| Approval Date: | Jul 1, 2013 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | EQ 10MG BASE | ||||
| Approval Date: | Jul 1, 2013 | TE: | AB | RLD: | No | ||||
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