MedPath
FDA Approval

Sildenafil

October 5, 2022

HUMAN PRESCRIPTION DRUG LABEL

Sildenafil(100 mg in 1 1)

Manufacturing Establishments (1)

Aphena Pharma Solutions - Tennessee, LLC

Aphena Pharma Solutions - Tennessee, LLC

128385585

Products (1)

Sildenafil

71610-237

ANDA077342

ANDA (C73584)

ORAL

October 5, 2022

CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5PClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
Code: BW9B0ZE037Class: ACTIMQuantity: 100 mg in 1 1
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