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Generated: May 28, 2017

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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 four 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. Eight suppliers are listed for this compound. Additional details are available on the caffeine; ergotamine tartrate profile page.

Summary for NDA: 040590

Formulation / Manufacturing:see details

Pharmacology for NDA: 040590

Suppliers and Packaging for NDA: 040590

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
caffeine; ergotamine tartrate
TABLET;ORAL 040590 ANDA KAISER FOUNDATION HOSPITALS 0179-0067 0179-0067-70 30 TABLET in 1 BOX, UNIT-DOSE (0179-0067-70)
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)

Summary for product number 001

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

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