Details for New Drug Application (NDA): 021016

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NDA 021016 describes RELPAX, which is a drug marketed by Upjohn and is included in one NDA. It is available from two suppliers. Additional details are available on the RELPAX profile page.

The generic ingredient in RELPAX is eletriptan hydrobromide. There are twelve drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the eletriptan hydrobromide profile page.

Summary for 021016

Tradename:	RELPAX
Applicant:	Upjohn
Ingredient:	eletriptan hydrobromide
Patents:	0

Pharmacology for NDA: 021016

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

Suppliers and Packaging for NDA: 021016

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RELPAX	eletriptan hydrobromide	TABLET;ORAL	021016	NDA	ROERIG	0049-2330	0049-2330-45	6 BLISTER PACK in 1 CARTON (0049-2330-45) / 1 TABLET, FILM COATED in 1 BLISTER PACK (0049-2330-79)
RELPAX	eletriptan hydrobromide	TABLET;ORAL	021016	NDA	ROERIG	0049-2340	0049-2340-05	12 BLISTER PACK in 1 CARTON (0049-2340-05) / 1 TABLET, FILM COATED in 1 BLISTER PACK (0049-2340-79)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 20MG BASE
Approval Date:	Dec 26, 2002	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 40MG BASE
Approval Date:	Dec 26, 2002	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021016

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Upjohn	RELPAX	eletriptan hydrobromide	TABLET;ORAL	021016-001	Dec 26, 2002	⤷ Sign Up	⤷ Sign Up
Upjohn	RELPAX	eletriptan hydrobromide	TABLET;ORAL	021016-002	Dec 26, 2002	⤷ Sign Up	⤷ Sign Up
Upjohn	RELPAX	eletriptan hydrobromide	TABLET;ORAL	021016-002	Dec 26, 2002	⤷ Sign Up	⤷ Sign Up
Upjohn	RELPAX	eletriptan hydrobromide	TABLET;ORAL	021016-001	Dec 26, 2002	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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