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Generated: November 17, 2018

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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 Pfizer Ireland and is included in one NDA. It is available from four 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. Ten suppliers are listed for this compound. Additional details are available on the eletriptan hydrobromide profile page.
Summary for 021016
Tradename:RELPAX
Applicant:Pfizer Ireland
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)

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
Pfizer Ireland RELPAX eletriptan hydrobromide TABLET;ORAL 021016-001 Dec 26, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
Pfizer Ireland RELPAX eletriptan hydrobromide TABLET;ORAL 021016-002 Dec 26, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
Pfizer Ireland RELPAX eletriptan hydrobromide TABLET;ORAL 021016-002 Dec 26, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
Pfizer Ireland RELPAX eletriptan hydrobromide TABLET;ORAL 021016-001 Dec 26, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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