MedPath
FDA Approval

Indapamide

July 13, 2023

HUMAN PRESCRIPTION DRUG LABEL

Indapamide(2.5 mg in 1 1)

Registrants (1)

Preferred Pharmaceuticals Inc.

791119022

Manufacturing Establishments (1)

Preferred Pharmaceuticals Inc.

Preferred Pharmaceuticals Inc.

Preferred Pharmaceuticals Inc.

791119022

Products (1)

Indapamide

68788-7247

ANDA074722

ANDA (C73584)

ORAL

July 13, 2023

Code: F089I0511LClass: ACTIBQuantity: 2.5 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2DClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IEClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
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