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Last Updated: November 5, 2024

Details for New Drug Application (NDA): 215816


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NDA 215816 describes PROPARACAINE HYDROCHLORIDE, which is a drug marketed by Bausch And Lomb, Rising, Sola Barnes Hind, and Somerset Theraps Llc, and is included in five NDAs. It is available from four suppliers. Additional details are available on the PROPARACAINE HYDROCHLORIDE profile page.

The generic ingredient in PROPARACAINE HYDROCHLORIDE is proparacaine hydrochloride. There is one drug master file entry for this compound. Six suppliers are listed for this compound. Additional details are available on the proparacaine hydrochloride profile page.
Summary for 215816
Pharmacology for NDA: 215816
Physiological EffectLocal Anesthesia
Suppliers and Packaging for NDA: 215816
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROPARACAINE HYDROCHLORIDE proparacaine hydrochloride SOLUTION/DROPS;OPHTHALMIC 215816 ANDA Somerset Therapeutics, LLC 70069-601 70069-601-01 1 BOTTLE in 1 CARTON (70069-601-01) / 15 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.5%
Approval Date:Aug 9, 2024TE:ATRLD:No

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