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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Federal Trade Commission
Express Scripts
Daiichi Sankyo
Harvard Business School

Generated: May 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040889

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NDA 040889 describes METHYLERGONOVINE MALEATE, which is a drug marketed by Breckenridge Pharm, Luitpold, Granules Pharms, and Novel Labs Inc, and is included in four NDAs. It is available from ten 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 040889
Applicant:Breckenridge Pharm
Ingredient:methylergonovine maleate
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 E 17478-501-01
METHYLERGONOVINE MALEATE methylergonovine maleate INJECTABLE;INJECTION 040889 ANDA Breckenridge Pharmaceutical, Inc. 51991-144 N 51991-144-17

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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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Federal Trade Commission

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