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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 040590


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NDA 040590 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 two 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. Three suppliers are listed for this compound. Additional details are available on the caffeine; ergotamine tartrate profile page.
Summary for 040590
Tradename:ERGOTAMINE TARTRATE AND CAFFEINE
Applicant:Mikart
Ingredient:caffeine; ergotamine tartrate
Patents:0
Pharmacology for NDA: 040590
Suppliers and Packaging for NDA: 040590
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ERGOTAMINE TARTRATE AND CAFFEINE caffeine; ergotamine tartrate TABLET;ORAL 040590 ANDA Cintex Services, LLC 24470-917 24470-917-10 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (24470-917-10)
ERGOTAMINE TARTRATE AND CAFFEINE caffeine; ergotamine tartrate TABLET;ORAL 040590 ANDA KMM Pharmaceuticals, LLC 52187-555 52187-555-10 100 TABLET in 1 BOTTLE (52187-555-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG;1MG
Approval Date:Sep 16, 2005TE:RLD:No

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