FARYDAK
These highlights do not include all the information needed to use FARYDAK safely and effectively. See full prescribing information for FARYDAK. FARYDAK (panobinostat) capsules, for oral use Initial U.S. Approval: 2015
Approved
Approval ID
1b97bd3a-1040-4511-b0e6-4758e8083ae5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 27, 2021
Manufacturers
FDA
Secura Bio, Inc.
DUNS: 117026236
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
panobinostat
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code73116-101
Application NumberNDA205353
Product Classification
M
Marketing Category
C73594
G
Generic Name
panobinostat
Product Specifications
Route of AdministrationORAL
Effective DateJuly 27, 2021
FDA Product Classification
INGREDIENTS (9)
PANOBINOSTAT LACTATEActive
Quantity: 15 mg in 1 1
Code: HN0T99OO4V
Classification: ACTIM
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
panobinostat
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code73116-102
Application NumberNDA205353
Product Classification
M
Marketing Category
C73594
G
Generic Name
panobinostat
Product Specifications
Route of AdministrationORAL
Effective DateJuly 27, 2021
FDA Product Classification
INGREDIENTS (8)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
PANOBINOSTAT LACTATEActive
Quantity: 20 mg in 1 1
Code: HN0T99OO4V
Classification: ACTIM
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
panobinostat
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code73116-100
Application NumberNDA205353
Product Classification
M
Marketing Category
C73594
G
Generic Name
panobinostat
Product Specifications
Route of AdministrationORAL
Effective DateJuly 27, 2021
FDA Product Classification
INGREDIENTS (9)
PANOBINOSTAT LACTATEActive
Quantity: 10 mg in 1 1
Code: HN0T99OO4V
Classification: ACTIM
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT