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Last Updated: July 3, 2020

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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 Theraps Llc and is included in one NDA. It is available from one supplier. Additional details are available on the ERGOMAR profile page.

The generic ingredient in ERGOMAR is ergotamine tartrate. There are thirteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ergotamine tartrate profile page.
Summary for 087693
Tradename:ERGOMAR
Applicant:Tersera Theraps Llc
Ingredient:ergotamine tartrate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 087693
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 TerSera Therapeutics, LLC 70720-120 70720-120-03 1 BLISTER PACK in 1 CARTON (70720-120-03) > 3 TABLET in 1 BLISTER PACK
ERGOMAR ergotamine tartrate TABLET;SUBLINGUAL 087693 ANDA TerSera Therapeutics, LLC 70720-120 70720-120-20 2 BLISTER PACK in 1 CARTON (70720-120-20) > 10 TABLET in 1 BLISTER PACK

Profile for product number 001

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

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