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Last Updated: May 22, 2024

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. Twenty-eight suppliers are listed for this compound. Additional details are available on the nicotine profile page.
Summary for 020385
Applicant:Pfizer Inc
Formulation / Manufacturing:see details
Pharmacology for NDA: 020385
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 & 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

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