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Last Updated: February 26, 2021

DrugPatentWatch Database Preview

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, Granules Pharms, Novel Labs Inc, Teva Pharms Usa, and Tulex Pharms Inc, and is included in seven 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 210424
Tradename:METHYLERGONOVINE MALEATE
Applicant:Granules Pharms
Ingredient:methylergonovine maleate
Patents:0
Formulation / Manufacturing:see details
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 West-Ward Pharmaceuticals Corp 0054-0639 0054-0639-03 7 TABLET in 1 BOTTLE (0054-0639-03)
METHYLERGONOVINE MALEATE methylergonovine maleate TABLET;ORAL 210424 ANDA West-Ward Pharmaceuticals Corp 0054-0639 0054-0639-05 12 TABLET in 1 BOTTLE (0054-0639-05)

Profile for product number 001

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

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