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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 Parke Davis and Pfizer Pharms and is included in three NDAs. It is available from five suppliers. There are two patents protecting this drug. Additional details are available on the NEURONTIN profile page.

The generic ingredient in NEURONTIN is gabapentin. There are twenty-six drug master file entries for this compound. Ninety-eight suppliers are listed for this compound. There are five tentative approvals for this compound. Additional details are available on the gabapentin profile page.

Summary for NDA: 021129

Parke Davis
Therapeutic Class:Anticonvulsants

Pharmacology for NDA: 021129

Suppliers and Packaging for NDA: 021129

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SOLUTION;ORAL 021129 NDA Parke-Davis Div of Pfizer Inc 0071-2012 0071-2012-23 470 mL in 1 BOTTLE (0071-2012-23)
SOLUTION;ORAL 021129 NDA AUTHORIZED GENERIC Greenstone LLC 59762-5025 59762-5025-1 470 mL in 1 BOTTLE, GLASS (59762-5025-1)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength250MG/5ML
Approval Date:Mar 2, 2000TE:AARLD:Yes
Patent:6,054,482*PEDPatent Expiration:Oct 25, 2017Product Flag?Substance Flag?Delist Request?Y
Patent:7,256,216*PEDPatent Expiration:Nov 28, 2022Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 021129

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Parke Davis
SOLUTION;ORAL021129-001Mar 2, 20004,894,476*PED<subscribe>
Parke Davis
SOLUTION;ORAL021129-001Mar 2, 20005,084,479*PED<subscribe>
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