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. 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-five 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:	1
Formulation / Manufacturing:	see details

Pharmacology for NDA: 021129

Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

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	0071-2012-44	1 BOTTLE in 1 CARTON (0071-2012-44) / 470 mL in 1 BOTTLE
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

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	250MG/5ML
Approval Date:	Mar 2, 2000	TE:	AA	RLD:	Yes
Patent:	⤷ Try a Trial	Patent Expiration:	Nov 28, 2022	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 021129

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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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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