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Last Updated: December 23, 2024

Details for New Drug Application (NDA): 090193

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NDA 090193 describes METHYLERGONOVINE MALEATE, which is a drug marketed by Am Regent, Breckenridge, Amneal Pharms, Chartwell Rx, Granules, Rising, Teva Pharms Usa, and Trupharma, and is included in eight NDAs. It is available from thirteen suppliers. Additional details are available on the METHYLERGONOVINE MALEATE profile page.

The generic ingredient in METHYLERGONOVINE MALEATE is methylergonovine maleate. There is one drug master file entry for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the methylergonovine maleate profile page.

Summary for 090193

Tradename:	METHYLERGONOVINE MALEATE
Applicant:	Am Regent
Ingredient:	methylergonovine maleate
Patents:	0

Pharmacology for NDA: 090193

Medical Subject Heading (MeSH) Categories for 090193

Oxytocics

Suppliers and Packaging for NDA: 090193

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METHYLERGONOVINE MALEATE	methylergonovine maleate	INJECTABLE;INJECTION	090193	ANDA	American Regent, Inc.	0517-0740	0517-0740-20	20 VIAL, SINGLE-DOSE in 1 CARTON (0517-0740-20) / 1 mL in 1 VIAL, SINGLE-DOSE (0517-0740-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	0.2MG/ML
Approval Date:	Nov 24, 2008	TE:	AP	RLD:	No

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