ENSACOVE
ENSACOVE (ensartinib) capsules, for oral use
Approved
Approval ID
1e1b2f79-678a-472a-b924-66909c8a4b2e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 26, 2024
Manufacturers
FDA
Xcovery Holdings, Inc.
DUNS: 033440609
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ensartinib
PRODUCT DETAILS
NDC Product Code83076-1100
Application NumberNDA218171
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateDecember 26, 2024
Generic Nameensartinib
INGREDIENTS (16)
ENSARTINIB HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: C2FR6VT1BQ
Classification: ACTIM
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
DEHYDRATED ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
ensartinib
PRODUCT DETAILS
NDC Product Code83076-1025
Application NumberNDA218171
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateDecember 26, 2024
Generic Nameensartinib
INGREDIENTS (12)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
DEHYDRATED ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
ENSARTINIB HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: C2FR6VT1BQ
Classification: ACTIB
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT