Ojjaara
These highlights do not include all the information needed to use OJJAARA safely and effectively. See full prescribing information for OJJAARA. OJJAARA (momelotinib) tablets, for oral useInitial U.S. Approval: 2023
Approved
Approval ID
4a672fd1-eb7b-4aa9-9b23-845e4b5dc400
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 15, 2023
Manufacturers
FDA
GlaxoSmithKline LLC
DUNS: 167380711
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Momelotinib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code81864-102
Application NumberNDA216873
Product Classification
M
Marketing Category
C73594
G
Generic Name
Momelotinib
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 15, 2023
FDA Product Classification
INGREDIENTS (13)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
PROPYL GALLATEInactive
Code: 8D4SNN7V92
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A CORNInactive
Code: AG9B65PV6B
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
MOMELOTINIB DIHYDROCHLORIDE MONOHYDRATEActive
Quantity: 150 mg in 1 1
Code: LDX8893L5D
Classification: ACTIM
Momelotinib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code81864-101
Application NumberNDA216873
Product Classification
M
Marketing Category
C73594
G
Generic Name
Momelotinib
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 15, 2023
FDA Product Classification
INGREDIENTS (13)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A CORNInactive
Code: AG9B65PV6B
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
PROPYL GALLATEInactive
Code: 8D4SNN7V92
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MOMELOTINIB DIHYDROCHLORIDE MONOHYDRATEActive
Quantity: 200 mg in 1 1
Code: LDX8893L5D
Classification: ACTIM
Momelotinib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code81864-103
Application NumberNDA216873
Product Classification
M
Marketing Category
C73594
G
Generic Name
Momelotinib
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 15, 2023
FDA Product Classification
INGREDIENTS (13)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MOMELOTINIB DIHYDROCHLORIDE MONOHYDRATEActive
Quantity: 100 mg in 1 1
Code: LDX8893L5D
Classification: ACTIM
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A CORNInactive
Code: AG9B65PV6B
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
PROPYL GALLATEInactive
Code: 8D4SNN7V92
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT