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Last Updated: January 25, 2020

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Details for New Drug Application (NDA): 021234

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NDA 021234 describes FLECTOR, which is a drug marketed by Inst Biochem and is included in one NDA. It is available from six suppliers. There is one patent protecting this drug and one Paragraph IV challenge. 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. Six suppliers are listed for this compound. Additional details are available on the diclofenac epolamine profile page.
Summary for 021234
Applicant:Inst Biochem
Ingredient:diclofenac epolamine
Formulation / Manufacturing:see details
Pharmacology for NDA: 021234
Suppliers and Packaging for NDA: 021234
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLECTOR diclofenac epolamine PATCH;TOPICAL 021234 NDA AUTHORIZED GENERIC Teva Pharmaceuticals USA Inc. 0093-3225 0093-3225-55 6 POUCH in 1 CARTON (0093-3225-55) > 5 PATCH in 1 POUCH (0093-3225-50)
FLECTOR diclofenac epolamine PATCH;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)
Paragraph IV (Patent) Challenges for 021234
Tradename Dosage Ingredient NDA Submissiondate
FLECTOR PATCH;TOPICAL diclofenac epolamine 021234 2015-06-26

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:PATCH;TOPICALStrength1.3%
Approval Date:Jan 31, 2007TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Apr 13, 2019Product Flag?YSubstance Flag?Delist Request?

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