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Last Updated: July 2, 2020

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Details for New Drug Application (NDA): 020235


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NDA 020235 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-nine drug master file entries for this compound. Seventy-three suppliers are listed for this compound. Additional details are available on the gabapentin profile page.
Summary for 020235
Tradename:NEURONTIN
Applicant:Pfizer Pharms
Ingredient:gabapentin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020235
Suppliers and Packaging for NDA: 020235
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NEURONTIN gabapentin CAPSULE;ORAL 020235 NDA Parke-Davis Div of Pfizer Inc 0071-0803 0071-0803-24 100 CAPSULE in 1 BOTTLE (0071-0803-24)
NEURONTIN gabapentin CAPSULE;ORAL 020235 NDA Parke-Davis Div of Pfizer Inc 0071-0805 0071-0805-24 100 CAPSULE in 1 BOTTLE (0071-0805-24)
Paragraph IV (Patent) Challenges for 020235
Tradename Dosage Ingredient NDA Submissiondate
NEURONTIN CAPSULE;ORAL gabapentin 020235

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Dec 30, 1993TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength300MG
Approval Date:Dec 30, 1993TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength400MG
Approval Date:Dec 30, 1993TE:ABRLD:Yes

Expired US Patents for NDA 020235

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer Pharms NEURONTIN gabapentin CAPSULE;ORAL 020235-002 Dec 30, 1993   Start Trial   Start Trial
Pfizer Pharms NEURONTIN gabapentin CAPSULE;ORAL 020235-002 Dec 30, 1993   Start Trial   Start Trial
Pfizer Pharms NEURONTIN gabapentin CAPSULE;ORAL 020235-001 Dec 30, 1993   Start Trial   Start Trial
Pfizer Pharms NEURONTIN gabapentin CAPSULE;ORAL 020235-002 Dec 30, 1993   Start Trial   Start Trial
Pfizer Pharms NEURONTIN gabapentin CAPSULE;ORAL 020235-001 Dec 30, 1993   Start Trial   Start Trial
Pfizer Pharms NEURONTIN gabapentin CAPSULE;ORAL 020235-003 Dec 30, 1993   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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