MedPath
FDA Approval

Digoxin

May 26, 2023

HUMAN PRESCRIPTION DRUG LABEL

Digoxin(125 ug in 1 1)

Registrants (1)

Oliva Therapeutics, LLC

118637856

Products (2)

Digoxin

82685-201

ANDA076268

ANDA (C73584)

ORAL

June 26, 2023

CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
DigoxinActive
Code: 73K4184T59Class: ACTIBQuantity: 125 ug in 1 1

Digoxin

82685-202

ANDA076268

ANDA (C73584)

ORAL

June 26, 2023

CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
DigoxinActive
Code: 73K4184T59Class: ACTIBQuantity: 250 ug in 1 1
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