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Generated: November 20, 2018

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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 three 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 eleven 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
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 0071-2012-23 470 mL in 1 BOTTLE (0071-2012-23)
NEURONTIN gabapentin SOLUTION;ORAL 021129 NDA AUTHORIZED GENERIC Greenstone LLC 59762-5025 59762-5025-1 470 mL in 1 BOTTLE, GLASS (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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