Last Updated: June 17, 2026

Details for New Drug Application (NDA): 020385

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NDA 020385 describes NICOTROL, which is a drug marketed by Mcneil Cons, Pfizer, and Pfizer Inc, and is included in three NDAs. It is available from one supplier. Additional details are available on the NICOTROL profile page.

The generic ingredient in NICOTROL is nicotine. There are thirty drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the nicotine profile page.

Summary for 020385

Tradename:	NICOTROL
Applicant:	Pfizer Inc
Ingredient:	nicotine
Patents:	0

Pharmacology for NDA: 020385

Medical Subject Heading (MeSH) Categories for 020385

Ganglionic Stimulants
Nicotinic Agonists

Suppliers and Packaging for NDA: 020385

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NICOTROL	nicotine	SPRAY, METERED;NASAL	020385	NDA	Pharmacia & Upjohn Company LLC	0009-5401	0009-5401-01	4 BOTTLE, SPRAY in 1 BOX (0009-5401-01) / 10 mL in 1 BOTTLE, SPRAY

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SPRAY, METERED;NASAL			Strength	0.5MG/SPRAY
Approval Date:	Mar 22, 1996	TE:		RLD:	Yes

Expired US Patents for NDA 020385

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer Inc	NICOTROL	nicotine	SPRAY, METERED;NASAL	020385-001	Mar 22, 1996	5,656,255	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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