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Last Updated: September 20, 2020

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Details for New Drug Application (NDA): 204090

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NDA 204090 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 Biotec Ltd, Sandoz, Unichem Labs Ltd, Alkem Labs Ltd, Celltrion, Eci Pharms Llc, Emcure Pharms Ltd, Glenmark Generics, Invagen Pharms, and Teva Pharms, and is included in twenty-five NDAs. It is available from twenty 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-one suppliers are listed for this compound. Additional details are available on the rizatriptan benzoate profile page.
Summary for 204090
Tradename:RIZATRIPTAN BENZOATE
Applicant:Emcure Pharms Ltd
Ingredient:rizatriptan benzoate
Patents:0
Pharmacology for NDA: 204090
Suppliers and Packaging for NDA: 204090
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RIZATRIPTAN BENZOATE rizatriptan benzoate TABLET;ORAL 204090 ANDA Heritage Pharmaceuticals Inc. 23155-244 23155-244-45 2 BLISTER PACK in 1 CARTON (23155-244-45) > 6 TABLET in 1 BLISTER PACK (23155-244-22)
RIZATRIPTAN BENZOATE rizatriptan benzoate TABLET;ORAL 204090 ANDA Heritage Pharmaceuticals Inc. 23155-244 23155-244-46 3 BLISTER PACK in 1 CARTON (23155-244-46) > 6 TABLET in 1 BLISTER PACK (23155-244-22)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Nov 26, 2013TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Nov 26, 2013TE:ABRLD:No

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