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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
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Johnson and Johnson
Daiichi Sankyo

Generated: May 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091577

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NDA 091577 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 091577
Applicant:Novel Labs Inc
Ingredient:methylergonovine maleate
Formulation / Manufacturing:see details
Pharmacology for NDA: 091577
Medical Subject Heading (MeSH) Categories for 091577
Suppliers and Packaging for NDA: 091577
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHYLERGONOVINE MALEATE methylergonovine maleate TABLET;ORAL 091577 ANDA KAISER FOUNDATION HOSPITALS 0179-0122 N 0179-0122-70
METHYLERGONOVINE MALEATE methylergonovine maleate TABLET;ORAL 091577 ANDA Lupin Pharma 27437-050 E 27437-050-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.2MG
Approval Date:May 2, 2011TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Johnson and Johnson
US Army
Cantor Fitzgerald
Chinese Patent Office

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