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
NDC Product Code25010-305
Application NumberNDA017871
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateJuly 1, 2021
Generic Namemetyrosine
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