Details for New Drug Application (NDA): 213734
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NDA 213734 describes METYROSINE, which is a drug marketed by Amneal and Leading and is included in two NDAs. It is available from one supplier. Additional details are available on the METYROSINE profile page.
The generic ingredient in METYROSINE is metyrosine. There are two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the metyrosine profile page.
The generic ingredient in METYROSINE is metyrosine. There are two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the metyrosine profile page.
Summary for 213734
| Tradename: | METYROSINE |
| Applicant: | Amneal |
| Ingredient: | metyrosine |
| Patents: | 0 |
Pharmacology for NDA: 213734
| Mechanism of Action | Catecholamine Synthesis Inhibitors |
Suppliers and Packaging for NDA: 213734
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| METYROSINE | metyrosine | CAPSULE;ORAL | 213734 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-1621 | 69238-1621-1 | 100 CAPSULE in 1 BOTTLE, PLASTIC (69238-1621-1) |
| METYROSINE | metyrosine | CAPSULE;ORAL | 213734 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-1621 | 69238-1621-3 | 30 CAPSULE in 1 BOTTLE, PLASTIC (69238-1621-3) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 250MG | ||||
| Approval Date: | Jul 24, 2020 | TE: | AB | RLD: | No | ||||
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