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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 204722


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NDA 204722 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 204722
Tradename:RIZATRIPTAN BENZOATE
Applicant:Panacea
Ingredient:rizatriptan benzoate
Patents:0
Pharmacology for NDA: 204722
Suppliers and Packaging for NDA: 204722
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RIZATRIPTAN BENZOATE rizatriptan benzoate TABLET, ORALLY DISINTEGRATING;ORAL 204722 ANDA Panacea Biotec Limited 43817-133 43817-133-04 6 BLISTER PACK in 1 CARTON (43817-133-04) / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (43817-133-03)
RIZATRIPTAN BENZOATE rizatriptan benzoate TABLET, ORALLY DISINTEGRATING;ORAL 204722 ANDA Panacea Biotec Limited 43817-135 43817-135-04 6 BLISTER PACK in 1 CARTON (43817-135-04) / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (43817-135-03)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrengthEQ 5MG BASE
Approval Date:Jan 11, 2017TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrengthEQ 10MG BASE
Approval Date:Jan 11, 2017TE:ABRLD:No

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