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FDA Approval

Nicotine Polacrilex

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

FDA Approval Summary

Company
Lucy Goods, Inc.
DUNS: 080875415
Effective Date
April 28, 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 Polacrilex

Product Details

NDC Product Code
72224-927
Application Number
ANDA078699
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
April 28, 2025
NicotineActive
Code: 6M3C89ZY6RClass: ACTIBQuantity: 2 mg in 1 1
ACACIAInactive
Code: 5C5403N26OClass: IACT
ACESULFAME POTASSIUMInactive
Code: 23OV73Q5G9Class: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZClass: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OHClass: IACT
MAGNESIUM OXIDEInactive
Code: 3A3U0GI71GClass: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
SODIUM CARBONATEInactive
Code: 45P3261C7TClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
XYLITOLInactive
Code: VCQ006KQ1EClass: IACT
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