ANZEMET
Anzemet
Approved
Approval ID
201b0eb8-4a1e-4e22-ab4b-addb642710d6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 12, 2023
Manufacturers
FDA
Validus Pharmaceuticals LLC
DUNS: 801194619
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
dolasetron mesylate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code30698-220
Application NumberNDA020623
Product Classification
M
Marketing Category
C73594
G
Generic Name
dolasetron mesylate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 8, 2023
FDA Product Classification
INGREDIENTS (10)
DOLASETRON MESYLATEActive
Quantity: 50 mg in 1 1
Code: U3C8E5BWKR
Classification: ACTIB
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT