Details for New Drug Application (NDA): 012911
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NDA 012911 describes METOPIRONE, which is a drug marketed by Esteve and is included in one NDA. It is available from two suppliers. 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. Two suppliers are listed for this compound. Additional details are available on the metyrapone profile page.
The generic ingredient in METOPIRONE is metyrapone. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the metyrapone profile page.
Summary for 012911
| Tradename: | METOPIRONE |
| Applicant: | Esteve |
| 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 | ESTEVE PHARMACEUTICALS, S.A. | 68118-455 | 68118-455-18 | 18 CAPSULE, GELATIN COATED in 1 BOTTLE (68118-455-18) |
| 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) |
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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