Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 20, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 012911

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NDA 012911 describes METOPIRONE, which is a drug marketed by Laboratorie Hra and is included in one NDA. It is available from one supplier. Additional details are available on the METOPIRONE profile page.

The generic ingredient in METOPIRONE is metyrapone. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the metyrapone profile page.
Summary for 012911
Tradename:METOPIRONE
Applicant:Laboratorie Hra
Ingredient:metyrapone
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 012911
Medical Subject Heading (MeSH) Categories for 012911
Suppliers and Packaging for NDA: 012911
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METOPIRONE metyrapone CAPSULE;ORAL 012911 NDA Laboratoire HRA Pharma 76336-455 76336-455-18 18 CAPSULE, GELATIN COATED in 1 BOTTLE (76336-455-18)
METOPIRONE metyrapone TABLET;ORAL 012911 NDA Laboratoire HRA Pharma 76336-455 76336-455-18 18 CAPSULE, GELATIN COATED in 1 BOTTLE (76336-455-18)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength250MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength250MG
Approval Date:Aug 9, 1996TE:RLD:Yes

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