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Last Updated: March 27, 2026

Details for New Drug Application (NDA): 212233

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NDA 212233 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 fourteen 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. Fourteen suppliers are listed for this compound. Additional details are available on the methylergonovine maleate profile page.

Summary for 212233

Tradename:	METHYLERGONOVINE MALEATE
Applicant:	Tp Anda Holdings
Ingredient:	methylergonovine maleate
Patents:	0

Pharmacology for NDA: 212233

Medical Subject Heading (MeSH) Categories for 212233

Oxytocics

Suppliers and Packaging for NDA: 212233

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METHYLERGONOVINE MALEATE	methylergonovine maleate	TABLET;ORAL	212233	ANDA	Volley Pharmaceuticals, LLC	83400-100	83400-100-12	12 TABLET in 1 BOTTLE (83400-100-12)
METHYLERGONOVINE MALEATE	methylergonovine maleate	TABLET;ORAL	212233	ANDA	Volley Pharmaceuticals, LLC	83400-100	83400-100-28	28 TABLET in 1 BOTTLE (83400-100-28)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.2MG
Approval Date:	May 1, 2020	TE:	AB	RLD:	No

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