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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 211483

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NDA 211483 describes METHYLERGONOVINE MALEATE, which is a drug marketed by Am Regent, Breckenridge, Amneal Pharms, Chartwell Rx, Granules, Rising, Teva Pharms Usa, and Tp Anda Holdings, 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 211483

Tradename:	METHYLERGONOVINE MALEATE
Applicant:	Amneal Pharms
Ingredient:	methylergonovine maleate
Patents:	0

Pharmacology for NDA: 211483

Medical Subject Heading (MeSH) Categories for 211483

Oxytocics

Suppliers and Packaging for NDA: 211483

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METHYLERGONOVINE MALEATE	methylergonovine maleate	TABLET;ORAL	211483	ANDA	Amneal Pharmaceuticals NY LLC	69238-1605	69238-1605-2	12 TABLET in 1 BOTTLE (69238-1605-2)
METHYLERGONOVINE MALEATE	methylergonovine maleate	TABLET;ORAL	211483	ANDA	Amneal Pharmaceuticals NY LLC	69238-1605	69238-1605-8	28 TABLET in 1 BOTTLE (69238-1605-8)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.2MG
Approval Date:	Sep 10, 2018	TE:	AB	RLD:	No

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