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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 Pharmacia And Upjohn, Mcneil Cons, and Pfizer Inc, and is included in three NDAs. It is available from four suppliers. Additional details are available on the NICOTROL profile page.

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

Summary for NDA: 020385

Tradename:
NICOTROL
Applicant:
Pfizer Inc
Ingredient:
nicotine
Patents:0
Therapeutic Class:Antidotes, Deterrents, and Toxicologic Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 020385

Ingredient-typeNicotine

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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;NASALStrength0.5MG/SPRAY
Approval Date:Mar 22, 1996TE:RLD:Yes

Expired Orange Book Patents for NDA: 020385

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer Inc
NICOTROL
nicotine
SPRAY, METERED;NASAL020385-001Mar 22, 19965,656,255► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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