MedPath
FDA Approval

Indapamide

June 26, 2023

Human Prescription Drug Label

Indapamide(1.25 mg in 1 1)

Manufacturing Establishments (1)

APPCO PHARMA LLC

Rising Pharma Holdings, Inc.

078510186

Products (2)

Indapamide

16571-875

ANDA074461

ANDA (C73584)

ORAL

June 26, 2023

Code: F089I0511LClass: ACTIBQuantity: 1.25 mg in 1 1
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IEClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
D&C RED NO. 30Inactive
Code: 2S42T2808BClass: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82Class: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693YClass: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3BClass: IACT

Indapamide

16571-876

ANDA074461

ANDA (C73584)

ORAL

June 26, 2023

ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
Code: F089I0511LClass: ACTIBQuantity: 2.5 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IEClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82Class: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
HYPROMELLOSE 2910 (50 MPA.S)Inactive
Code: 1IVH67816NClass: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693YClass: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3BClass: IACT
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