Demser
DEMSER (metyrosine) Capsules
Approved
Approval ID
32fb2f2f-34b5-4cd5-9145-c3ab37c5ca92
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 1, 2021
Manufacturers
FDA
Bausch Health US, LLC
DUNS: 831922468
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
metyrosine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code25010-305
Application NumberNDA017871
Product Classification
M
Marketing Category
C73594
G
Generic Name
metyrosine
Product Specifications
Route of AdministrationORAL
Effective DateJuly 1, 2021
FDA Product Classification
INGREDIENTS (7)
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
metyrosineActive
Quantity: 250 mg in 1 1
Code: DOQ0J0TPF7
Classification: ACTIB
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C Blue No. 2Inactive
Code: L06K8R7DQK
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT