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Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Product Details

NDC Product Code

15054-0010

Application Number

NDA215559

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

August 24, 2023

Ingredients

PalovaroteneActive

Code: 28K6I5M16GClass: ACTIBQuantity: 1 mg in 1 1

croscarmellose sodiumInactive

Code: M28OL1HH48Class: IACT

magnesium stearateInactive

Code: 70097M6I30Class: IACT

microcrystalline celluloseInactive

Code: OP1R32D61UClass: IACT

lactose monohydrateInactive

Code: EWQ57Q8I5XClass: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94EClass: IACT

sodium lauryl sulfateInactive

Code: 368GB5141JClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

Titanium DioxideInactive

Code: 15FIX9V2JPClass: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

propylene glycolInactive

Code: 6DC9Q167V3Class: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

shellacInactive

Code: 46N107B71OClass: IACT

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Product Details

NDC Product Code

15054-0050

Application Number

NDA215559

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

August 24, 2023

Ingredients

croscarmellose sodiumInactive

Code: M28OL1HH48Class: IACT

PalovaroteneActive

Code: 28K6I5M16GClass: ACTIBQuantity: 5 mg in 1 1

lactose monohydrateInactive

Code: EWQ57Q8I5XClass: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94EClass: IACT

magnesium stearateInactive

Code: 70097M6I30Class: IACT

microcrystalline celluloseInactive

Code: OP1R32D61UClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

sodium lauryl sulfateInactive

Code: 368GB5141JClass: IACT

Titanium DioxideInactive

Code: 15FIX9V2JPClass: IACT

propylene glycolInactive

Code: 6DC9Q167V3Class: IACT

shellacInactive

Code: 46N107B71OClass: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

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Product Details

NDC Product Code

15054-0100

Application Number

NDA215559

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

August 24, 2023

Ingredients

lactose monohydrateInactive

Code: EWQ57Q8I5XClass: IACT

PalovaroteneActive

Code: 28K6I5M16GClass: ACTIBQuantity: 10 mg in 1 1

microcrystalline celluloseInactive

Code: OP1R32D61UClass: IACT

croscarmellose sodiumInactive

Code: M28OL1HH48Class: IACT

magnesium stearateInactive

Code: 70097M6I30Class: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94EClass: IACT

sodium lauryl sulfateInactive

Code: 368GB5141JClass: IACT

Titanium DioxideInactive

Code: 15FIX9V2JPClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

propylene glycolInactive

Code: 6DC9Q167V3Class: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

shellacInactive

Code: 46N107B71OClass: IACT

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Product Details

NDC Product Code

15054-0025

Application Number

NDA215559

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

August 24, 2023

Ingredients

PalovaroteneActive

Code: 28K6I5M16GClass: ACTIBQuantity: 2.5 mg in 1 1

magnesium stearateInactive

Code: 70097M6I30Class: IACT

lactose monohydrateInactive

Code: EWQ57Q8I5XClass: IACT

croscarmellose sodiumInactive

Code: M28OL1HH48Class: IACT

microcrystalline celluloseInactive

Code: OP1R32D61UClass: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94EClass: IACT

sodium lauryl sulfateInactive

Code: 368GB5141JClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

Titanium DioxideInactive

Code: 15FIX9V2JPClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

propylene glycolInactive

Code: 6DC9Q167V3Class: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

shellacInactive

Code: 46N107B71OClass: IACT

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Product Details

NDC Product Code

15054-0015

Application Number

NDA215559

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

August 24, 2023

Ingredients

PalovaroteneActive

Code: 28K6I5M16GClass: ACTIBQuantity: 1.5 mg in 1 1

lactose monohydrateInactive

Code: EWQ57Q8I5XClass: IACT

croscarmellose sodiumInactive

Code: M28OL1HH48Class: IACT

magnesium stearateInactive

Code: 70097M6I30Class: IACT

microcrystalline celluloseInactive

Code: OP1R32D61UClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94EClass: IACT

sodium lauryl sulfateInactive

Code: 368GB5141JClass: IACT

Titanium DioxideInactive

Code: 15FIX9V2JPClass: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

propylene glycolInactive

Code: 6DC9Q167V3Class: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

shellacInactive

Code: 46N107B71OClass: IACT

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