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Last Updated: July 7, 2020

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Details for New Drug Application (NDA): 020864


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NDA 020864 describes MAXALT, which is a drug marketed by Merck and is included in two NDAs. It is available from one supplier. Additional details are available on the MAXALT profile page.

The generic ingredient in MAXALT is rizatriptan benzoate. There are twenty-two drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the rizatriptan benzoate profile page.
Summary for 020864
Tradename:MAXALT
Applicant:Merck
Ingredient:rizatriptan benzoate
Patents:0
Pharmacology for NDA: 020864
Suppliers and Packaging for NDA: 020864
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MAXALT rizatriptan benzoate TABLET;ORAL 020864 NDA Merck Sharp & Dohme Corp. 0006-0266 0006-0266-18 18 POUCH in 1 CARTON (0006-0266-18) > 1 TABLET in 1 POUCH (0006-0266-01)
MAXALT rizatriptan benzoate TABLET;ORAL 020864 NDA Merck Sharp & Dohme Corp. 0006-0267 0006-0267-18 18 POUCH in 1 CARTON (0006-0267-18) > 1 TABLET in 1 POUCH (0006-0267-01)
Paragraph IV (Patent) Challenges for 020864
Tradename Dosage Ingredient NDA Submissiondate
MAXALT TABLET;ORAL rizatriptan benzoate 020864 2004-09-02

Profile for product number 001

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5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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

Profile for product number 002

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

Expired US Patents for NDA 020864

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck MAXALT rizatriptan benzoate TABLET;ORAL 020864-001 Jun 29, 1998   Start Trial   Start Trial
Merck MAXALT rizatriptan benzoate TABLET;ORAL 020864-002 Jun 29, 1998   Start Trial   Start Trial
Merck MAXALT rizatriptan benzoate TABLET;ORAL 020864-002 Jun 29, 1998   Start Trial   Start Trial
Merck MAXALT rizatriptan benzoate TABLET;ORAL 020864-001 Jun 29, 1998   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

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Mallinckrodt
Express Scripts
Dow

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