MedPath
FDA Approval

Nicotine Polacrilex

January 29, 2025

HUMAN OTC DRUG LABEL

Nicotine(4 mg in 1 1)

Products (1)

Nicotine Polacrilex

55910-976

ANDA078697

ANDA (C73584)

ORAL

January 29, 2025

ACESULFAME POTASSIUMInactive
Code: 23OV73Q5G9Class: IACT
ACACIAInactive
Code: 5C5403N26OClass: IACT
XYLITOLInactive
Code: VCQ006KQ1EClass: IACT
NicotineActive
Code: 6M3C89ZY6RClass: ACTIBQuantity: 4 mg in 1 1
CARNAUBA WAXInactive
Code: R12CBM0EIZClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
MAGNESIUM OXIDEInactive
Code: 3A3U0GI71GClass: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OHClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
SODIUM CARBONATEInactive
Code: 45P3261C7TClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
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