Details for New Drug Application (NDA): 020882

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NDA 020882 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-eight suppliers are listed for this compound. Additional details are available on the gabapentin profile page.

Summary for 020882

Tradename:	NEURONTIN
Applicant:	Viatris
Ingredient:	gabapentin
Patents:	0

Pharmacology for NDA: 020882

Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

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:	RX	Dosage:	TABLET;ORAL			Strength	600MG
Approval Date:	Oct 9, 1998	TE:	AB1	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	800MG
Approval Date:	Oct 9, 1998	TE:	AB1	RLD:	Yes

Expired US Patents for NDA 020882

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