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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 five suppliers. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the RELPAX profile page.

The generic ingredient in RELPAX is eletriptan hydrobromide. There are eleven drug master file entries for this compound. Five suppliers are listed for this compound. There are eight tentative approvals for this compound. Additional details are available on the eletriptan hydrobromide profile page.

Summary for NDA: 021016

Tradename:
RELPAX
Applicant:
Pfizer Ireland
Ingredient:
eletriptan hydrobromide
Patents:2

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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Dec 26, 2002TE:RLD:No
Patent:6,110,940Patent Expiration:Aug 29, 2017Product Flag?Substance Flag?Delist Request?
Patent:5,545,644Patent Expiration:Dec 26, 2016Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF MIGRAINE WITH OR WITHOUT AURA

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 40MG BASE
Approval Date:Dec 26, 2002TE:RLD:Yes
Patent:6,110,940Patent Expiration:Aug 29, 2017Product Flag?Substance Flag?Delist Request?


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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