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Generated: February 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040510

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NDA 040510 describes ERGOTAMINE TARTRATE AND CAFFEINE, which is a drug marketed by Hikma Intl Pharms and Mikart and is included in two NDAs. It is available from three suppliers. Additional details are available on the ERGOTAMINE TARTRATE AND CAFFEINE profile page.

The generic ingredient in ERGOTAMINE TARTRATE AND CAFFEINE is caffeine; ergotamine tartrate. There are eleven drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the caffeine; ergotamine tartrate profile page.
Summary for 040510
Tradename:ERGOTAMINE TARTRATE AND CAFFEINE
Applicant:Hikma Intl Pharms
Ingredient:caffeine; ergotamine tartrate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 040510
Suppliers and Packaging for NDA: 040510
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ERGOTAMINE TARTRATE AND CAFFEINE caffeine; ergotamine tartrate TABLET;ORAL 040510 ANDA West-Ward Pharmaceutical Corp 0143-2120 N 0143-2120-05
ERGOTAMINE TARTRATE AND CAFFEINE caffeine; ergotamine tartrate TABLET;ORAL 040510 ANDA West-Ward Pharmaceutical Corp 0143-2120 N 0143-2120-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG;1MG
Approval Date:Sep 17, 2004TE:AARLD:No

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