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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 201967


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NDA 201967 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.
Summary for 201967
Tradename:RIZATRIPTAN BENZOATE
Applicant:Glenmark Pharms Ltd
Ingredient:rizatriptan benzoate
Patents:0
Pharmacology for NDA: 201967
Suppliers and Packaging for NDA: 201967
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RIZATRIPTAN BENZOATE rizatriptan benzoate TABLET;ORAL 201967 ANDA Glenmark Pharmaceuticals Inc., USA 68462-465 68462-465-72 12 POUCH in 1 CARTON (68462-465-72) / 1 BLISTER PACK in 1 POUCH / 1 TABLET in 1 BLISTER PACK
RIZATRIPTAN BENZOATE rizatriptan benzoate TABLET;ORAL 201967 ANDA Glenmark Pharmaceuticals Inc., USA 68462-465 68462-465-99 18 POUCH in 1 CARTON (68462-465-99) / 1 BLISTER PACK in 1 POUCH / 1 TABLET in 1 BLISTER PACK

Profile for product number 001

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

Profile for product number 002

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

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