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Last Updated: February 26, 2021

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Details for New Drug Application (NDA): 040889

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NDA 040889 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 040889
Tradename:METHYLERGONOVINE MALEATE
Applicant:Breckenridge
Ingredient:methylergonovine maleate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 040889
Medical Subject Heading (MeSH) Categories for 040889
Suppliers and Packaging for NDA: 040889
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHYLERGONOVINE MALEATE methylergonovine maleate INJECTABLE;INJECTION 040889 ANDA Akorn, Inc. 17478-501 17478-501-01 10 AMPULE in 1 CARTON (17478-501-01) > 1 mL in 1 AMPULE
METHYLERGONOVINE MALEATE methylergonovine maleate INJECTABLE;INJECTION 040889 ANDA A-S Medication Solutions 50090-4536 50090-4536-0 1 mL in 1 AMPULE (50090-4536-0)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.2MG/ML
Approval Date:Sep 13, 2010TE:APRLD:No

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