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Generated: April 26, 2017

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Details for New Drug Application (NDA): 084294

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NDA 084294 describes CAFERGOT, which is a drug marketed by Novartis and Sandoz and is included in three NDAs. It is available from two suppliers. Additional details are available on the CAFERGOT profile page.

The generic ingredient in CAFERGOT 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: 084294

Formulation / Manufacturing:see details

Pharmacology for NDA: 084294

Suppliers and Packaging for NDA: 084294

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
caffeine; ergotamine tartrate
TABLET;ORAL 084294 ANDA KAISER FOUNDATION HOSPITALS 0179-0089 0179-0089-70 30 TABLET in 1 BOX, UNIT-DOSE (0179-0089-70)
caffeine; ergotamine tartrate
TABLET;ORAL 084294 ANDA Sandoz Inc 0781-5405 0781-5405-01 100 TABLET, FILM COATED in 1 BOTTLE (0781-5405-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG;1MG
Approval Date:Approved Prior to Jan 1, 1982TE:AARLD:No

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