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Generated: June 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 086557

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NDA 086557 describes MIGERGOT, which is a drug marketed by Horizon Pharma and is included in one NDA. It is available from two suppliers. Additional details are available on the MIGERGOT profile page.

The generic ingredient in MIGERGOT 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 086557
Applicant:Horizon Pharma
Ingredient:caffeine; ergotamine tartrate
Formulation / Manufacturing:see details
Pharmacology for NDA: 086557
Suppliers and Packaging for NDA: 086557
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MIGERGOT caffeine; ergotamine tartrate SUPPOSITORY;RECTAL 086557 ANDA G&W Laboratories, Inc. 0713-0166 N 0713-0166-12
MIGERGOT caffeine; ergotamine tartrate SUPPOSITORY;RECTAL 086557 ANDA Horizon Pharma Inc. 75987-090 N 75987-090-11

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUPPOSITORY;RECTALStrength100MG;2MG
Approval Date:Oct 4, 1983TE:RLD:No

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