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Last Updated: June 22, 2021

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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 three 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
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)
Paragraph IV (Patent) Challenges for 021016
Tradename Dosage Ingredient NDA Submissiondate
RELPAX TABLET;ORAL eletriptan hydrobromide 021016 2010-03-29

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Dec 26, 2002TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 40MG BASE
Approval Date:Dec 26, 2002TE:ABRLD:Yes

Expired US Patents for NDA 021016

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

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