Details for New Drug Application (NDA): 018422

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NDA 018422 describes LOPID, which is a drug marketed by Pfizer Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the LOPID profile page.

The generic ingredient in LOPID is gemfibrozil. Thirty-four suppliers are listed for this compound. Additional details are available on the gemfibrozil profile page.

Summary for 018422

Tradename:	LOPID
Applicant:	Pfizer Pharms
Ingredient:	gemfibrozil
Patents:	0

Pharmacology for NDA: 018422

Mechanism of Action	Peroxisome Proliferator-activated Receptor alpha Agonists

Medical Subject Heading (MeSH) Categories for 018422

Cytochrome P-450 CYP2C8 Inhibitors
Hypolipidemic Agents

Suppliers and Packaging for NDA: 018422

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LOPID	gemfibrozil	CAPSULE;ORAL	018422	NDA	Parke-Davis Div of Pfizer Inc	0071-0737	0071-0737-20	60 TABLET, FILM COATED in 1 BOTTLE (0071-0737-20)
LOPID	gemfibrozil	TABLET;ORAL	018422	NDA	Parke-Davis Div of Pfizer Inc	0071-0737	0071-0737-20	60 TABLET, FILM COATED in 1 BOTTLE (0071-0737-20)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	200MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	300MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	600MG
Approval Date:	Nov 20, 1986	TE:	AB	RLD:	Yes

Expired US Patents for NDA 018422

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer Pharms	LOPID	gemfibrozil	CAPSULE;ORAL	018422-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Pfizer Pharms	LOPID	gemfibrozil	CAPSULE;ORAL	018422-002	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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