Details for New Drug Application (NDA): 020864

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NDA 020864 describes MAXALT, which is a drug marketed by Organon Llc and Organon 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-four suppliers are listed for this compound. Additional details are available on the rizatriptan benzoate profile page.

Summary for 020864

Tradename:	MAXALT
Applicant:	Organon Llc
Ingredient:	rizatriptan benzoate
Patents:	0

Pharmacology for NDA: 020864

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

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	Organon LLC	78206-142	78206-142-01	18 POUCH in 1 CARTON (78206-142-01) / 1 TABLET in 1 POUCH (78206-142-99)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jun 29, 1998	TE:		RLD:	Yes

Profile for product number 002

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

Expired US Patents for NDA 020864

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon Llc	MAXALT	rizatriptan benzoate	TABLET;ORAL	020864-001	Jun 29, 1998	⤷ Sign Up	⤷ Sign Up
Organon Llc	MAXALT	rizatriptan benzoate	TABLET;ORAL	020864-002	Jun 29, 1998	⤷ Sign Up	⤷ Sign Up
Organon Llc	MAXALT	rizatriptan benzoate	TABLET;ORAL	020864-002	Jun 29, 1998	⤷ Sign Up	⤷ Sign Up
Organon Llc	MAXALT	rizatriptan benzoate	TABLET;ORAL	020864-001	Jun 29, 1998	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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