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Last Updated: November 24, 2024

Details for New Drug Application (NDA): 020865


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NDA 020865 describes MAXALT-MLT, which is a drug marketed by Organon and is included in one NDA. It is available from one supplier. Additional details are available on the MAXALT-MLT profile page.

The generic ingredient in MAXALT-MLT is rizatriptan benzoate. There are twenty-two drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the rizatriptan benzoate profile page.
Summary for 020865
Tradename:MAXALT-MLT
Applicant:Organon
Ingredient:rizatriptan benzoate
Patents:0
Pharmacology for NDA: 020865
Suppliers and Packaging for NDA: 020865
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MAXALT-MLT rizatriptan benzoate TABLET, ORALLY DISINTEGRATING;ORAL 020865 NDA Organon LLC 78206-143 78206-143-01 6 CONTAINER in 1 CARTON (78206-143-01) / 3 POUCH in 1 CONTAINER / 1 BLISTER PACK in 1 POUCH (78206-143-99) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, ORALLY DISINTEGRATING;ORALStrengthEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Jun 29, 1998TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrengthEQ 10MG BASE
Approval Date:Jun 29, 1998TE:ABRLD:Yes

Expired US Patents for NDA 020865

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Organon MAXALT-MLT rizatriptan benzoate TABLET, ORALLY DISINTEGRATING;ORAL 020865-002 Jun 29, 1998 ⤷  Sign Up ⤷  Sign Up
Organon MAXALT-MLT rizatriptan benzoate TABLET, ORALLY DISINTEGRATING;ORAL 020865-001 Jun 29, 1998 ⤷  Sign Up ⤷  Sign Up
Organon MAXALT-MLT rizatriptan benzoate TABLET, ORALLY DISINTEGRATING;ORAL 020865-001 Jun 29, 1998 ⤷  Sign Up ⤷  Sign Up
Organon MAXALT-MLT rizatriptan benzoate TABLET, ORALLY DISINTEGRATING;ORAL 020865-001 Jun 29, 1998 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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