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

Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

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:	RX	Dosage:	CAPSULE;ORAL			Strength	100MG
Approval Date:	Dec 30, 1993	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	300MG
Approval Date:	Dec 30, 1993	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	400MG
Approval Date:	Dec 30, 1993	TE:	AB	RLD:	Yes

Expired US Patents for NDA 020235

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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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