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Generated: January 24, 2019

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Details for New Drug Application (NDA): 200482

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NDA 200482 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, Cipla Ltd, 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-six 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-eight suppliers are listed for this compound. Additional details are available on the rizatriptan benzoate profile page.
Summary for 200482
Tradename:RIZATRIPTAN BENZOATE
Applicant:Natco Pharma Ltd
Ingredient:rizatriptan benzoate
Patents:0
Pharmacology for NDA: 200482
Suppliers and Packaging for NDA: 200482
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RIZATRIPTAN BENZOATE rizatriptan benzoate TABLET;ORAL 200482 ANDA Medsource Pharmaceuticals 45865-825 45865-825-12 2 BLISTER PACK in 1 CARTON (45865-825-12) > 6 TABLET in 1 BLISTER PACK
RIZATRIPTAN BENZOATE rizatriptan benzoate TABLET;ORAL 200482 ANDA A-S Medication Solutions 50090-3921 50090-3921-0 18 BLISTER PACK in 1 CARTON (50090-3921-0) > 6 TABLET in 1 BLISTER PACK

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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