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FDA Approval

PYLERA

Company

H2-Pharma, LLC (DUNS: 028473634)

Effective Date

October 19, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Bismuth subcitrate potassium(140 mg in 1 1)

Metronidazole(125 mg in 1 1)

Tetracycline(125 mg in 1 1)

Products (1)

PYLERA

NDC Product Code

61269-380

Application Number

NDA050786

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

October 19, 2023

Ingredients

Bismuth subcitrate potassiumActive

Code: R3O80H60KXClass: ACTIBQuantity: 140 mg in 1 1

MetronidazoleActive

Code: 140QMO216EClass: ACTIBQuantity: 125 mg in 1 1

TetracyclineActive

Code: P6R62377KVClass: ACTIBQuantity: 125 mg in 1 1

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

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