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Details for New Drug Application (NDA): 203269

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NDA 203269 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-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: 203269

Alkem Labs Ltd
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
TABLET;ORAL 203269 ANDA Ascend Laboratories, LLC 67877-261 67877-261-01 100 TABLET in 1 BOTTLE (67877-261-01)
rizatriptan benzoate
TABLET;ORAL 203269 ANDA Ascend Laboratories, LLC 67877-261 67877-261-05 500 TABLET in 1 BOTTLE (67877-261-05)

Summary for product number 001

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

Summary for product number 002

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

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