Details for New Drug Application (NDA): 012911
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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: | Hra Pharma |
Ingredient: | metyrapone |
Patents: | 0 |
Pharmacology for NDA: 012911
Mechanism of Action | Adrenal Steroid Synthesis Inhibitors |
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 | HRA Pharma Rare Diseases | 76336-455 | 76336-455-18 | 18 CAPSULE, GELATIN COATED in 1 BOTTLE (76336-455-18) |
METOPIRONE | metyrapone | TABLET;ORAL | 012911 | NDA | HRA Pharma Rare Diseases | 76336-455 | 76336-455-18 | 18 CAPSULE, GELATIN COATED in 1 BOTTLE (76336-455-18) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 250MG | ||||
Approval Date: | Aug 9, 1996 | TE: | RLD: | Yes |
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