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

Mechanism of Action	Serotonin 1b Receptor Agonists Serotonin 1d Receptor Agonists

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:	DISCN	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	EQ 5MG BASE
Approval Date:	Jun 29, 1998	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	EQ 10MG BASE
Approval Date:	Jun 29, 1998	TE:	AB	RLD:	Yes

Expired US Patents for NDA 020865

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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	020865-002	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
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

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