MedPath
FDA Approval

Losartan Potassium

May 31, 2018

HUMAN PRESCRIPTION DRUG LABEL

Losartan(25 mg in 1 1)

Manufacturing Establishments (1)

Aphena Pharma Solutions - Tennessee, LLC

Aphena Pharma Solutions - Tennessee, LLC

128385585

Products (1)

Losartan Potassium

71610-065

ANDA076958

ANDA (C73584)

ORAL

May 31, 2018

LosartanActive
Code: 3ST302B24AClass: ACTIBQuantity: 25 mg in 1 1
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933Class: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
INDIGOTINDISULFONATE SODIUMInactive
Code: D3741U8K7LClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5PClass: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95Class: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
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