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Generated: November 20, 2018

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Details for New Drug Application (NDA): 203146

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NDA 203146 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 203146
Tradename:RIZATRIPTAN BENZOATE
Applicant:Macleods Pharms Ltd
Ingredient:rizatriptan benzoate
Patents:0
Pharmacology for NDA: 203146
Suppliers and Packaging for NDA: 203146
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RIZATRIPTAN BENZOATE rizatriptan benzoate TABLET, ORALLY DISINTEGRATING;ORAL 203146 ANDA Macleods Pharmaceuticals Limited 33342-093 33342-093-07 30 TABLET, ORALLY DISINTEGRATING in 1 CONTAINER (33342-093-07)
RIZATRIPTAN BENZOATE rizatriptan benzoate TABLET, ORALLY DISINTEGRATING;ORAL 203146 ANDA Macleods Pharmaceuticals Limited 33342-093 33342-093-12 10 BLISTER PACK in 1 CARTON (33342-093-12) > 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrengthEQ 5MG BASE
Approval Date:Sep 19, 2014TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrengthEQ 10MG BASE
Approval Date:Sep 19, 2014TE:ABRLD:No

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