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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 077263


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NDA 077263 describes RIZATRIPTAN BENZOATE, which is a drug marketed by Apotex Inc, Aurobindo Pharma Ltd, Glenmark Pharms Ltd, Jubilant Generics, Macleods Pharms Ltd, Mylan Pharms Inc, Natco Pharma Ltd, Panacea, Sandoz, Unichem, Alkem Labs Ltd, Avet Lifesciences, Chartwell Rx, Creekwood Pharms, Glenmark Generics, Invagen Pharms, 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.
Summary for 077263
Tradename:RIZATRIPTAN BENZOATE
Applicant:Teva Pharms
Ingredient:rizatriptan benzoate
Patents:0
Pharmacology for NDA: 077263
Suppliers and Packaging for NDA: 077263
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RIZATRIPTAN BENZOATE rizatriptan benzoate TABLET;ORAL 077263 ANDA Teva Pharmaceuticals USA, Inc. 0093-7471 0093-7471-43 18 BLISTER PACK in 1 BOX (0093-7471-43) / 1 TABLET in 1 BLISTER PACK (0093-7471-19)
RIZATRIPTAN BENZOATE rizatriptan benzoate TABLET;ORAL 077263 ANDA Teva Pharmaceuticals USA, Inc. 0093-7472 0093-7472-43 18 BLISTER PACK in 1 BOX (0093-7472-43) / 1 TABLET in 1 BLISTER PACK (0093-7472-19)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Dec 31, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Dec 31, 2012TE:ABRLD:No

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