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Generated: April 29, 2017

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Details for New Drug Application (NDA): 087693

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NDA 087693 describes ERGOMAR, which is a drug marketed by Tersera Therap and is included in one NDA. It is available from two suppliers. Additional details are available on the ERGOMAR profile page.

The generic ingredient in ERGOMAR is ergotamine tartrate. There are twelve drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the ergotamine tartrate profile page.

Summary for NDA: 087693

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Antimigraine Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 087693

Ingredient-typeErgotamines

Suppliers and Packaging for NDA: 087693

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ERGOMAR
ergotamine tartrate
TABLET;SUBLINGUAL 087693 ANDA Rosedale Therapeutics 10802-1202 10802-1202-0 20 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, UNIT-DOSE (10802-1202-0)
ERGOMAR
ergotamine tartrate
TABLET;SUBLINGUAL 087693 ANDA Rosedale Therapeutics 10802-1202 10802-1202-3 3 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, UNIT-DOSE (10802-1202-3)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;SUBLINGUALStrength2MG
Approval Date:Feb 24, 1983TE:RLD:No


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