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Generated: November 20, 2018

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Details for New Drug Application (NDA): 020385

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NDA 020385 describes NICOTROL, which is a drug marketed by Mcneil Cons, Pharmacia And Upjohn, and Pfizer Inc, and is included in three NDAs. It is available from three suppliers. 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-three 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 020385
Ingredient-typeNicotine
Medical Subject Heading (MeSH) Categories for 020385
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 and 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:RXDosage:SPRAY, METERED;NASALStrength0.5MG/SPRAY
Approval Date:Mar 22, 1996TE:RLD:Yes

Expired US Patents for NDA 020385

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer Inc NICOTROL nicotine SPRAY, METERED;NASAL 020385-001 Mar 22, 1996 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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