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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 021129


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NDA 021129 describes NEURONTIN, which is a drug marketed by Viatris and is included in three NDAs. It is available from two suppliers. 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-six suppliers are listed for this compound. Additional details are available on the gabapentin profile page.
Summary for 021129
Tradename:NEURONTIN
Applicant:Viatris
Ingredient:gabapentin
Patents:0
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 0071-2012-47 1 BOTTLE, PLASTIC in 1 CARTON (0071-2012-47) / 470 mL in 1 BOTTLE, PLASTIC
NEURONTIN gabapentin SOLUTION;ORAL 021129 NDA AUTHORIZED GENERIC Greenstone LLC 59762-5050 59762-5050-7 1 BOTTLE, PLASTIC in 1 CARTON (59762-5050-7) / 470 mL in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength250MG/5ML
Approval Date:Mar 2, 2000TE:AARLD:Yes

Expired US Patents for NDA 021129

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Viatris NEURONTIN gabapentin SOLUTION;ORAL 021129-001 Mar 2, 2000 ⤷  Try a Trial ⤷  Try a Trial
Viatris NEURONTIN gabapentin SOLUTION;ORAL 021129-001 Mar 2, 2000 ⤷  Try a Trial ⤷  Try a Trial
Viatris NEURONTIN gabapentin SOLUTION;ORAL 021129-001 Mar 2, 2000 ⤷  Try a Trial ⤷  Try a Trial
Viatris NEURONTIN gabapentin SOLUTION;ORAL 021129-001 Mar 2, 2000 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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