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Generated: April 21, 2019

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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 eleven 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. Eleven suppliers are listed for this compound. Additional details are available on the diclofenac epolamine profile page.
Summary for 021234
Tradename:FLECTOR
Applicant:Inst Biochem
Ingredient:diclofenac epolamine
Patents:1
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 Rebel Distributors Corp 21695-707 21695-707-01 1 PATCH in 1 PACKAGE (21695-707-01)

Profile for product number 001

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

Expired US Patents for NDA 021234

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Inst Biochem FLECTOR diclofenac epolamine PATCH;TOPICAL 021234-001 Jan 31, 2007 ➤ Try a Free Trial ➤ Try a Free Trial
Inst Biochem FLECTOR diclofenac epolamine PATCH;TOPICAL 021234-001 Jan 31, 2007 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Covington
Mallinckrodt
Express Scripts
AstraZeneca
Chinese Patent Office

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