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FDA Approval

Nicotrol

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

FDA Approval Summary

Company
Effective Date
May 31, 2022
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Nicotine(10 mg in 1 mL)

Products1

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

Nicotrol

Product Details

NDC Product Code
0009-5401
Application Number
NDA020385
Marketing Category
NDA (C73594)
Route of Administration
NASAL
Effective Date
May 31, 2022
NicotineActive
Code: 6M3C89ZY6RClass: ACTIBQuantity: 10 mg in 1 mL
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMInactive
Code: 3980JIH2SWClass: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OHClass: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
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