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FDA Approval

Good Sense Nicotine

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

FDA Approval Summary

Company
L. Perrigo Company
DUNS: 006013346
Effective Date
March 21, 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.

Good Sense Nicotine

Product Details

NDC Product Code
0113-0029
Application Number
ANDA076775
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
March 21, 2025
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
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
SODIUM CARBONATEInactive
Code: 45P3261C7TClass: IACT
SORBITOLInactive
Code: 506T60A25RClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
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