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Details for New Drug Application (NDA): 021717

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NDA 021717 describes PLIAGLIS, which is a drug marketed by Galderma Labs Lp and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the PLIAGLIS profile page.

The generic ingredient in PLIAGLIS is lidocaine; tetracaine. There are twenty-nine drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the lidocaine; tetracaine profile page.

Summary for NDA: 021717

Galderma Labs Lp
lidocaine; tetracaine

Pharmacology for NDA: 021717

Physiological EffectLocal Anesthesia

Suppliers and Packaging for NDA: 021717

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
lidocaine; tetracaine
CREAM;TOPICAL 021717 NDA Galderma Laboratories, L.P. 0299-6100 0299-6100-10 1 TUBE in 1 CARTON (0299-6100-10) > 100 g in 1 TUBE
lidocaine; tetracaine
CREAM;TOPICAL 021717 NDA Galderma Laboratories, L.P. 0299-6100 0299-6100-30 1 TUBE in 1 CARTON (0299-6100-30) > 30 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength7%;7%
Approval Date:Jun 29, 2006TE:RLD:Yes
Patent:5,919,479Patent Expiration:Jul 28, 2015Product Flag?YSubstance Flag?Delist Request?
Patent:6,528,086Patent Expiration:Sep 28, 2019Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 021717

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Galderma Labs Lp
lidocaine; tetracaine
CREAM;TOPICAL021717-001Jun 29, 20065,919,479► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.