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US Department of Justice

Generated: May 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021129

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NDA 021129 describes NEURONTIN, which is a drug marketed by Pfizer Pharms and Parke Davis and is included in three NDAs. It is available from two suppliers. There is one patent protecting this drug. Additional details are available on the NEURONTIN profile page.

The generic ingredient in NEURONTIN is gabapentin. There are twenty-eight drug master file entries for this compound. One hundred and nine suppliers are listed for this compound. Additional details are available on the gabapentin profile page.
Summary for 021129
Tradename:NEURONTIN
Applicant:Parke Davis
Ingredient:gabapentin
Patents:1
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details
Pharmacology for NDA: 021129
Suppliers and Packaging for NDA: 021129
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NEURONTIN gabapentin SOLUTION;ORAL 021129 NDA Parke-Davis Div of Pfizer Inc 0071-2012 N 0071-2012-23
NEURONTIN gabapentin SOLUTION;ORAL 021129 NDA AUTHORIZED GENERIC Greenstone LLC 59762-5025 N 59762-5025-1

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength250MG/5ML
Approval Date:Mar 2, 2000TE:AARLD:Yes
Patent:➤ Sign UpPatent Expiration:Nov 28, 2022Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 021129

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Parke Davis NEURONTIN gabapentin SOLUTION;ORAL 021129-001 Mar 2, 2000 ➤ Sign Up ➤ Sign Up
Parke Davis NEURONTIN gabapentin SOLUTION;ORAL 021129-001 Mar 2, 2000 ➤ Sign Up ➤ Sign Up
Parke Davis NEURONTIN gabapentin SOLUTION;ORAL 021129-001 Mar 2, 2000 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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