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Last Updated: April 19, 2024

Details for New Drug Application (NDA): 021234

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NDA 021234 describes FLECTOR, which is a drug marketed by Ibsa and is included in one NDA. It is available from seven suppliers. Additional details are available on the FLECTOR profile page.

The generic ingredient in FLECTOR is diclofenac epolamine. There are forty-seven drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the diclofenac epolamine profile page.

Summary for 021234

Tradename:	FLECTOR
Applicant:	Ibsa
Ingredient:	diclofenac epolamine
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 021234

Mechanism of Action	Cyclooxygenase Inhibitors
Physiological Effect	Decreased Prostaglandin Production

Suppliers and Packaging for NDA: 021234

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FLECTOR	diclofenac epolamine	SYSTEM;TOPICAL	021234	NDA AUTHORIZED GENERIC	Teva Pharmaceuticals USA Inc.	0093-3727	0093-3727-55	6 POUCH in 1 CARTON (0093-3727-55) / 5 SYSTEM in 1 POUCH (0093-3727-50)
FLECTOR	diclofenac epolamine	SYSTEM;TOPICAL	021234	NDA AUTHORIZED GENERIC	Quality Care Products, LLC	55700-886	55700-886-30	6 POUCH in 1 CARTON (55700-886-30) / 5 SYSTEM in 1 POUCH

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SYSTEM;TOPICAL			Strength	1.3%
Approval Date:	Jan 31, 2007	TE:		RLD:	Yes

Expired US Patents for NDA 021234

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ibsa	FLECTOR	diclofenac epolamine	SYSTEM;TOPICAL	021234-001	Jan 31, 2007	⤷ Try a Trial	⤷ Try a Trial
Ibsa	FLECTOR	diclofenac epolamine	SYSTEM;TOPICAL	021234-001	Jan 31, 2007	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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