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Details for New Drug Application (NDA): 202047

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NDA 202047 describes RIZATRIPTAN BENZOATE, which is a drug marketed by Glenmark Generics, 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-two NDAs. It is available from twenty-three 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 NDA: 202047

Nostrum Labs Inc
rizatriptan benzoate
Therapeutic Class:Antimigraine Agents

Pharmacology for NDA: 202047

Suppliers and Packaging for NDA: 202047

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
rizatriptan benzoate
TABLET;ORAL 202047 ANDA Sun Pharma Global FZE 47335-231 47335-231-18 1000 TABLET in 1 BOTTLE (47335-231-18)
rizatriptan benzoate
TABLET;ORAL 202047 ANDA Sun Pharma Global FZE 47335-231 47335-231-62 4 BLISTER PACK in 1 CARTON (47335-231-62) > 3 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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