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Generated: November 16, 2018

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Details for New Drug Application (NDA): 020882

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NDA 020882 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 020882
Tradename:NEURONTIN
Applicant:Pfizer Pharms
Ingredient:gabapentin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020882
Suppliers and Packaging for NDA: 020882
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NEURONTIN gabapentin TABLET;ORAL 020882 NDA Parke-Davis Div of Pfizer Inc 0071-0401 0071-0401-24 100 TABLET, FILM COATED in 1 BOTTLE (0071-0401-24)
NEURONTIN gabapentin TABLET;ORAL 020882 NDA Parke-Davis Div of Pfizer Inc 0071-0513 0071-0513-24 100 TABLET, FILM COATED in 1 BOTTLE (0071-0513-24)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength600MG
Approval Date:Oct 9, 1998TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength800MG
Approval Date:Oct 9, 1998TE:ABRLD:Yes

Expired US Patents for NDA 020882

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer Pharms NEURONTIN gabapentin TABLET;ORAL 020882-002 Oct 9, 1998 ➤ Sign Up ➤ Sign Up
Pfizer Pharms NEURONTIN gabapentin TABLET;ORAL 020882-001 Oct 9, 1998 ➤ Sign Up ➤ Sign Up
Pfizer Pharms NEURONTIN gabapentin TABLET;ORAL 020882-001 Oct 9, 1998 ➤ Sign Up ➤ Sign Up
Pfizer Pharms NEURONTIN gabapentin TABLET;ORAL 020882-002 Oct 9, 1998 ➤ Sign Up ➤ Sign Up
Pfizer Pharms NEURONTIN gabapentin TABLET;ORAL 020882-001 Oct 9, 1998 ➤ Sign Up ➤ Sign Up
Pfizer Pharms NEURONTIN gabapentin TABLET;ORAL 020882-002 Oct 9, 1998 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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