SOHONOS
These highlights do not include all the information needed to use SOHONOS™ safely and effectively. See full prescribing information for SOHONOS. SOHONOS (palovarotene) capsules, for oral use Initial U.S. Approval: 2023
Approved
Approval ID
67dce406-7cc4-4d66-92de-ad18b6df0625
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 24, 2023
Manufacturers
FDA
Ipsen Biopharmaceuticals, Inc.
DUNS: 118461578
Products 5
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
palovarotene
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code15054-0010
Application NumberNDA215559
Product Classification
M
Marketing Category
C73594
G
Generic Name
palovarotene
Product Specifications
Route of AdministrationORAL
Effective DateAugust 24, 2023
FDA Product Classification
INGREDIENTS (13)
palovaroteneActive
Quantity: 1 mg in 1 1
Code: 28K6I5M16G
Classification: ACTIB
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
microcrystalline celluloseInactive
Code: OP1R32D61U
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
shellacInactive
Code: 46N107B71O
Classification: IACT
palovarotene
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code15054-0050
Application NumberNDA215559
Product Classification
M
Marketing Category
C73594
G
Generic Name
palovarotene
Product Specifications
Route of AdministrationORAL
Effective DateAugust 24, 2023
FDA Product Classification
INGREDIENTS (13)
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
palovaroteneActive
Quantity: 5 mg in 1 1
Code: 28K6I5M16G
Classification: ACTIB
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
microcrystalline celluloseInactive
Code: OP1R32D61U
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
shellacInactive
Code: 46N107B71O
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
palovarotene
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code15054-0100
Application NumberNDA215559
Product Classification
M
Marketing Category
C73594
G
Generic Name
palovarotene
Product Specifications
Route of AdministrationORAL
Effective DateAugust 24, 2023
FDA Product Classification
INGREDIENTS (13)
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
palovaroteneActive
Quantity: 10 mg in 1 1
Code: 28K6I5M16G
Classification: ACTIB
microcrystalline celluloseInactive
Code: OP1R32D61U
Classification: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
shellacInactive
Code: 46N107B71O
Classification: IACT
palovarotene
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code15054-0025
Application NumberNDA215559
Product Classification
M
Marketing Category
C73594
G
Generic Name
palovarotene
Product Specifications
Route of AdministrationORAL
Effective DateAugust 24, 2023
FDA Product Classification
INGREDIENTS (13)
palovaroteneActive
Quantity: 2.5 mg in 1 1
Code: 28K6I5M16G
Classification: ACTIB
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
microcrystalline celluloseInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
shellacInactive
Code: 46N107B71O
Classification: IACT
palovarotene
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code15054-0015
Application NumberNDA215559
Product Classification
M
Marketing Category
C73594
G
Generic Name
palovarotene
Product Specifications
Route of AdministrationORAL
Effective DateAugust 24, 2023
FDA Product Classification
INGREDIENTS (13)
palovaroteneActive
Quantity: 1.5 mg in 1 1
Code: 28K6I5M16G
Classification: ACTIB
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
microcrystalline celluloseInactive
Code: OP1R32D61U
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
shellacInactive
Code: 46N107B71O
Classification: IACT