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FDA Approval

Nicotine

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
February 18, 2025
Labeling Type
HUMAN OTC DRUG LABEL
Nicotine(2 mg in 1 1)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Nicotine

Product Details

NDC Product Code
41250-456
Application Number
ANDA076777
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
February 18, 2025
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
SODIUM CARBONATEInactive
Code: 45P3261C7TClass: IACT
SORBITOLInactive
Code: 506T60A25RClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
XYLITOLInactive
Code: VCQ006KQ1EClass: IACT
NicotineActive
Code: 6M3C89ZY6RClass: ACTIBQuantity: 2 mg in 1 1
POLACRILINInactive
Code: RCZ785HI7SClass: IACT
ACESULFAME POTASSIUMInactive
Code: 23OV73Q5G9Class: IACT
CALCIUM CARBONATEInactive
Code: H0G9379FGKClass: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZClass: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
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