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Harvard Business School

Last Updated: February 26, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 211455

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NDA 211455 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 211455
Applicant:Teva Pharms Usa
Ingredient:methylergonovine maleate
Formulation / Manufacturing:see details
Pharmacology for NDA: 211455
Medical Subject Heading (MeSH) Categories for 211455
Suppliers and Packaging for NDA: 211455
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHYLERGONOVINE MALEATE methylergonovine maleate TABLET;ORAL 211455 ANDA Teva Pharmaceuticals USA, Inc. 0093-3655 0093-3655-22 12 TABLET in 1 BOTTLE (0093-3655-22)
METHYLERGONOVINE MALEATE methylergonovine maleate TABLET;ORAL 211455 ANDA Teva Pharmaceuticals USA, Inc. 0093-3655 0093-3655-28 28 TABLET in 1 BOTTLE (0093-3655-28)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.2MG
Approval Date:Mar 20, 2019TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson

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