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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 Glenmark Generics, Panacea Biotec Ltd, Cipla Ltd, Sandoz, Jubilant Generics, Invagen Pharms, Apotex Inc, Macleods Pharms Ltd, Nostrum Labs Inc, Aurobindo Pharma Ltd, Teva Pharms, Alkem Labs Ltd, Mylan Pharms Inc, Natco Pharma Ltd, and Emcure Pharms Ltd, and is included in twenty-three NDAs. It is available from twenty-four 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-nine suppliers are listed for this compound. Additional details are available on the rizatriptan benzoate profile page.

Summary for NDA: 200482

Natco Pharma Ltd
rizatriptan benzoate
Therapeutic Class:Antimigraine Agents

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
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
TABLET;ORAL 200482 ANDA Mesource Pharmaceuticals 45865-844 45865-844-18 18 BLISTER PACK in 1 CARTON (45865-844-18) > 6 TABLET in 1 BLISTER PACK

Summary for product number 001

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

Summary for product number 002

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

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