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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 204339


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NDA 204339 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 204339
Tradename:RIZATRIPTAN BENZOATE
Applicant:Invagen Pharms
Ingredient:rizatriptan benzoate
Patents:0
Pharmacology for NDA: 204339
Suppliers and Packaging for NDA: 204339
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RIZATRIPTAN BENZOATE rizatriptan benzoate TABLET;ORAL 204339 ANDA RPK Pharmaceuticals, Inc. 53002-1713 53002-1713-1 3 TABLET in 1 CARTON (53002-1713-1)
RIZATRIPTAN BENZOATE rizatriptan benzoate TABLET;ORAL 204339 ANDA DIRECT RX 61919-394 61919-394-18 18 TABLET in 1 BLISTER PACK (61919-394-18)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Jul 1, 2013TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Jul 1, 2013TE:RLD:No

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