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Details for New Drug Application (NDA): 012911

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NDA 012911 describes METOPIRONE, which is a drug marketed by Hra Pharma 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 NDA: 012911

Tradename:
METOPIRONE
Applicant:
Hra Pharma
Ingredient:
metyrapone
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 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)

Summary for product number 001

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

Summary for product number 002

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


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