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Details for New Drug Application (NDA): 088388

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NDA 088388 describes SCANDONEST L, which is a drug marketed by Deproco and is included in one NDA. It is available from six suppliers. Additional details are available on the SCANDONEST L profile page.

The generic ingredient in SCANDONEST L is levonordefrin; mepivacaine hydrochloride. There are two drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the levonordefrin; mepivacaine hydrochloride profile page.

Summary for NDA: 088388

levonordefrin; mepivacaine hydrochloride
Formulation / Manufacturing:see details

Pharmacology for NDA: 088388

Physiological EffectLocal Anesthesia

Suppliers and Packaging for NDA: 088388

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
levonordefrin; mepivacaine hydrochloride
INJECTABLE;INJECTION 088388 ANDA Henry Schein Inc. 0404-6740 0404-6740-05 5 BLISTER PACK in 1 CARTON (0404-6740-05) > 10 CARTRIDGE in 1 BLISTER PACK > 1.7 mL in 1 CARTRIDGE
levonordefrin; mepivacaine hydrochloride
INJECTABLE;INJECTION 088388 ANDA Caresteam Health, Inc. 31382-931 31382-931-05 5 BLISTER PACK in 1 CARTON (31382-931-05) > 10 CARTRIDGE in 1 BLISTER PACK > 1.7 mL in 1 CARTRIDGE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.05MG/ML;2%
Approval Date:Oct 10, 1984TE:RLD:No

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