MedPath
FDA Approval

SOAANZ

January 16, 2024

HUMAN PRESCRIPTION DRUG LABEL

Torasemide(40 mg in 1 1)

Products (6)

SOAANZ

73502-287

NDA213218

NDA (C73594)

ORAL

December 28, 2021

Code: W31X2H97FBClass: ACTIBQuantity: 40 mg in 1 1
Silicon DioxideInactive
Code: ETJ7Z6XBU4Class: IACT
Ferric Oxide YellowInactive
Code: EX438O2MRTClass: IACT
Ferric Oxide RedInactive
Code: 1K09F3G675Class: IACT
Lactose, unspecified formInactive
Code: J2B2A4N98GClass: IACT
Magnesium StearateInactive
Code: 70097M6I30Class: IACT
Microcrystalline Cellulose 101Inactive
Code: 7T9FYH5QMKClass: IACT
TalcInactive
Code: 7SEV7J4R1UClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
Titanium DioxideInactive
Code: 15FIX9V2JPClass: IACT

SOAANZ

73502-286

NDA213218

NDA (C73594)

ORAL

December 28, 2021

Code: W31X2H97FBClass: ACTIBQuantity: 20 mg in 1 1
Ferric Oxide YellowInactive
Code: EX438O2MRTClass: IACT
Silicon DioxideInactive
Code: ETJ7Z6XBU4Class: IACT
Ferric Oxide RedInactive
Code: 1K09F3G675Class: IACT
Lactose, unspecified formInactive
Code: J2B2A4N98GClass: IACT
Magnesium StearateInactive
Code: 70097M6I30Class: IACT
TalcInactive
Code: 7SEV7J4R1UClass: IACT
Microcrystalline Cellulose 101Inactive
Code: 7T9FYH5QMKClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
Titanium DioxideInactive
Code: 15FIX9V2JPClass: IACT

SOAANZ

73502-586

NDA213218

NDA (C73594)

ORAL

December 28, 2021

Ferric Oxide RedInactive
Code: 1K09F3G675Class: IACT
Silicon DioxideInactive
Code: ETJ7Z6XBU4Class: IACT
Code: W31X2H97FBClass: ACTIBQuantity: 40 mg in 1 1
Ferric Oxide YellowInactive
Code: EX438O2MRTClass: IACT
Lactose, unspecified formInactive
Code: J2B2A4N98GClass: IACT
Magnesium StearateInactive
Code: 70097M6I30Class: IACT
Microcrystalline Cellulose 101Inactive
Code: 7T9FYH5QMKClass: IACT
TalcInactive
Code: 7SEV7J4R1UClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
Titanium DioxideInactive
Code: 15FIX9V2JPClass: IACT

SOAANZ

73502-786

NDA213218

NDA (C73594)

ORAL

December 28, 2021

Silicon DioxideInactive
Code: ETJ7Z6XBU4Class: IACT
Code: W31X2H97FBClass: ACTIBQuantity: 20 mg in 1 1
Ferric Oxide RedInactive
Code: 1K09F3G675Class: IACT
Ferric Oxide YellowInactive
Code: EX438O2MRTClass: IACT
Magnesium StearateInactive
Code: 70097M6I30Class: IACT
TalcInactive
Code: 7SEV7J4R1UClass: IACT
Lactose, unspecified formInactive
Code: J2B2A4N98GClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
Titanium DioxideInactive
Code: 15FIX9V2JPClass: IACT
Microcrystalline Cellulose 101Inactive
Code: 7T9FYH5QMKClass: IACT

SOAANZ

73502-687

NDA213218

NDA (C73594)

ORAL

December 28, 2021

Silicon DioxideInactive
Code: ETJ7Z6XBU4Class: IACT
Code: W31X2H97FBClass: ACTIBQuantity: 60 mg in 1 1
Ferric Oxide YellowInactive
Code: EX438O2MRTClass: IACT
Ferric Oxide RedInactive
Code: 1K09F3G675Class: IACT
Lactose, unspecified formInactive
Code: J2B2A4N98GClass: IACT
Magnesium StearateInactive
Code: 70097M6I30Class: IACT
Microcrystalline Cellulose 101Inactive
Code: 7T9FYH5QMKClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
Titanium DioxideInactive
Code: 15FIX9V2JPClass: IACT
TalcInactive
Code: 7SEV7J4R1UClass: IACT

SOAANZ

73502-288

NDA213218

NDA (C73594)

ORAL

December 28, 2021

Code: W31X2H97FBClass: ACTIBQuantity: 60 mg in 1 1
Silicon DioxideInactive
Code: ETJ7Z6XBU4Class: IACT
Lactose, unspecified formInactive
Code: J2B2A4N98GClass: IACT
Ferric Oxide RedInactive
Code: 1K09F3G675Class: IACT
Microcrystalline Cellulose 101Inactive
Code: 7T9FYH5QMKClass: IACT
Magnesium StearateInactive
Code: 70097M6I30Class: IACT
Titanium DioxideInactive
Code: 15FIX9V2JPClass: IACT
TalcInactive
Code: 7SEV7J4R1UClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
Ferric Oxide YellowInactive
Code: EX438O2MRTClass: IACT
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