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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 210424


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NDA 210424 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 210424
Tradename:METHYLERGONOVINE MALEATE
Applicant:Granules
Ingredient:methylergonovine maleate
Patents:0
Pharmacology for NDA: 210424
Medical Subject Heading (MeSH) Categories for 210424
Suppliers and Packaging for NDA: 210424
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHYLERGONOVINE MALEATE methylergonovine maleate TABLET;ORAL 210424 ANDA Major Pharmaceuticals 0904-7282 0904-7282-10 20 BLISTER PACK in 1 CARTON (0904-7282-10) / 1 TABLET in 1 BLISTER PACK
METHYLERGONOVINE MALEATE methylergonovine maleate TABLET;ORAL 210424 ANDA American Health Packaging 60687-813 60687-813-94 20 BLISTER PACK in 1 CARTON (60687-813-94) / 1 TABLET in 1 BLISTER PACK (60687-813-11)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.2MG
Approval Date:May 15, 2018TE:ABRLD:No

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