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Generated: January 17, 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 nine 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. Nine 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
Generic Entry Opportunity Date for 021234
Generic Entry Date for 021234*:
Constraining patent/regulatory exclusivity:

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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 Rebel Distributors Corp 21695-707 21695-707-01 1 PATCH in 1 PACKAGE (21695-707-01)
FLECTOR diclofenac epolamine PATCH;TOPICAL 021234 NDA Rebel Distributors Corp 21695-707 21695-707-30 30 PATCH in 1 BOX (21695-707-30)

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?

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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Harvard Business School

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