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Generated: November 20, 2018

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Details for New Drug Application (NDA): 020865

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NDA 020865 describes MAXALT-MLT, which is a drug marketed by Merck 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-eight suppliers are listed for this compound. Additional details are available on the rizatriptan benzoate profile page.
Summary for 020865
Tradename:MAXALT-MLT
Applicant:Merck
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 Merck Sharp & Dohme Corp. 0006-3800 0006-3800-18 6 CONTAINER in 1 CARTON (0006-3800-18) > 3 POUCH in 1 CONTAINER > 1 BLISTER PACK in 1 POUCH (0006-3800-01) > 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
MAXALT-MLT rizatriptan benzoate TABLET, ORALLY DISINTEGRATING;ORAL 020865 NDA Merck Sharp & Dohme Corp. 0006-3801 0006-3801-18 6 CONTAINER in 1 CARTON (0006-3801-18) > 3 POUCH in 1 CONTAINER > 1 BLISTER PACK in 1 POUCH (0006-3801-01) > 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, ORALLY DISINTEGRATING;ORALStrengthEQ 5MG BASE
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
Merck MAXALT-MLT rizatriptan benzoate TABLET, ORALLY DISINTEGRATING;ORAL 020865-002 Jun 29, 1998 ➤ Sign Up ➤ Sign Up
Merck MAXALT-MLT rizatriptan benzoate TABLET, ORALLY DISINTEGRATING;ORAL 020865-001 Jun 29, 1998 ➤ Sign Up ➤ Sign Up
Merck MAXALT-MLT rizatriptan benzoate TABLET, ORALLY DISINTEGRATING;ORAL 020865-001 Jun 29, 1998 ➤ Sign Up ➤ Sign Up
Merck MAXALT-MLT rizatriptan benzoate TABLET, ORALLY DISINTEGRATING;ORAL 020865-001 Jun 29, 1998 ➤ Sign Up ➤ Sign Up
Merck MAXALT-MLT rizatriptan benzoate TABLET, ORALLY DISINTEGRATING;ORAL 020865-002 Jun 29, 1998 ➤ Sign Up ➤ Sign Up
Merck MAXALT-MLT rizatriptan benzoate TABLET, ORALLY DISINTEGRATING;ORAL 020865-002 Jun 29, 1998 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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