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Last Updated: November 4, 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
Pharmacology for NDA: 021234
Mechanism of ActionCyclooxygenase Inhibitors
Physiological EffectDecreased 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:RXDosage:SYSTEM;TOPICALStrength1.3%
Approval Date:Jan 31, 2007TE:RLD:Yes

Expired US Patents for NDA 021234

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

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