Details for New Drug Application (NDA): 017871
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NDA 017871 describes DEMSER, which is a drug marketed by Bausch and is included in one NDA. It is available from two suppliers. Additional details are available on the DEMSER profile page.
The generic ingredient in DEMSER 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 DEMSER 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 017871
| Tradename: | DEMSER |
| Applicant: | Bausch |
| Ingredient: | metyrosine |
| Patents: | 0 |
Pharmacology for NDA: 017871
| Mechanism of Action | Catecholamine Synthesis Inhibitors |
Suppliers and Packaging for NDA: 017871
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DEMSER | metyrosine | CAPSULE;ORAL | 017871 | NDA | Bausch Health US, LLC | 25010-305 | 25010-305-15 | 100 CAPSULE in 1 BOTTLE (25010-305-15) |
| DEMSER | metyrosine | CAPSULE;ORAL | 017871 | NDA AUTHORIZED GENERIC | Oceanside Pharmaceuticals | 68682-310 | 68682-310-01 | 100 CAPSULE in 1 BOTTLE (68682-310-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 250MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes | ||||
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