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Generated: December 15, 2018

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Details for New Drug Application (NDA): 021902

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NDA 021902 describes VEREGEN, which is a drug marketed by Fougera Pharms Inc and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the VEREGEN profile page.

The generic ingredient in VEREGEN is sinecatechins. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the sinecatechins profile page.
Summary for 021902
Tradename:VEREGEN
Applicant:Fougera Pharms Inc
Ingredient:sinecatechins
Patents:3
Generic Entry Opportunity Date for 021902
Generic Entry Date for 021902*:
Constraining patent/regulatory exclusivity:
Dosage:
OINTMENT;TOPICAL

*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.

Suppliers and Packaging for NDA: 021902
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VEREGEN sinecatechins OINTMENT;TOPICAL 021902 NDA PharmaDerm a division of Fougera Pharmaceuticals Inc. 10337-450 10337-450-03 1 TUBE in 1 CARTON (10337-450-03) > 30 g in 1 TUBE
VEREGEN sinecatechins OINTMENT;TOPICAL 021902 NDA PharmaDerm a division of Fougera Pharmaceuticals Inc. 10337-450 10337-450-08 1 TUBE in 1 CARTON (10337-450-08) > 2 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;TOPICALStrength15%
Approval Date:Oct 31, 2006TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Oct 31, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF GENITAL WARTS
Patent:➤ Try a Free TrialPatent Expiration:Oct 2, 2026Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF GENITAL WARTS
Patent:➤ Try a Free TrialPatent Expiration:Jul 12, 2025Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF GENITAL WARTS

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