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Last Updated: July 6, 2020

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Details for New Drug Application (NDA): 211527

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NDA 211527 describes AKLIEF, which is a drug marketed by Galderma Labs Lp and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the AKLIEF profile page.

The generic ingredient in AKLIEF is trifarotene. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the trifarotene profile page.
Summary for 211527
Applicant:Galderma Labs Lp
Generic Entry Opportunity Date for 211527
Generic Entry Date for 211527*:
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.

Suppliers and Packaging for NDA: 211527
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AKLIEF trifarotene CREAM;TOPICAL 211527 NDA Galderma Laboratories, L.P. 0299-5935 0299-5935-02 1 TUBE in 1 BLISTER PACK (0299-5935-02) > 2 g in 1 TUBE
AKLIEF trifarotene CREAM;TOPICAL 211527 NDA Galderma Laboratories, L.P. 0299-5935 0299-5935-30 1 BOTTLE, PUMP in 1 CARTON (0299-5935-30) > 30 g in 1 BOTTLE, PUMP

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.005%
Approval Date:Oct 4, 2019TE:RLD:Yes
Regulatory Exclusivity Expiration:Oct 4, 2024
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:  Start TrialPatent Expiration:Oct 1, 2026Product Flag?YSubstance Flag?YDelist Request?
Patent:  Start TrialPatent Expiration:Dec 21, 2025Product Flag?Substance Flag?Delist Request?

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