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Serving leading biopharmaceutical companies globally:

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Federal Trade Commission
Queensland Health
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Generated: February 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203269

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NDA 203269 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-five 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 203269
Applicant:Alkem Labs Ltd
Ingredient:rizatriptan benzoate
Therapeutic Class:Antimigraine Agents
Pharmacology for NDA: 203269
Suppliers and Packaging for NDA: 203269
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RIZATRIPTAN BENZOATE rizatriptan benzoate TABLET;ORAL 203269 ANDA Ascend Laboratories, LLC 67877-261 N 67877-261-18
RIZATRIPTAN BENZOATE rizatriptan benzoate TABLET;ORAL 203269 ANDA Ascend Laboratories, LLC 67877-261 N 67877-261-25

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Feb 18, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Feb 18, 2016TE:ABRLD:No

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