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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 ten 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 NDA: 086557

Tradename:
MIGERGOT
Applicant:
Horizon Pharma
Ingredient:
caffeine; ergotamine tartrate
Patents:0
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 0713-0166-12 12 SUPPOSITORY in 1 BOX (0713-0166-12)
MIGERGOT
caffeine; ergotamine tartrate
SUPPOSITORY;RECTAL 086557 ANDA Crealta Pharmaceuticals LLC 60809-166 60809-166-12 12 SUPPOSITORY in 1 CARTON (60809-166-12)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUPPOSITORY;RECTALStrength100MG;2MG
Approval Date:Oct 4, 1983TE:RLD:Yes


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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