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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-nine 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

Tradename:
NEURONTIN
Applicant:
Parke Davis
Ingredient:
gabapentin
Patents:2
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 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)

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

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