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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 219294

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NDA 219294 describes PROPARACAINE HYDROCHLORIDE, which is a drug marketed by Bausch And Lomb, Mankind Pharma, Micro Labs, Rising, Sola Barnes Hind, and Somerset Theraps Llc, and is included in seven NDAs. It is available from eight 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. Eleven suppliers are listed for this compound. Additional details are available on the proparacaine hydrochloride profile page.

Summary for 219294

Tradename:	PROPARACAINE HYDROCHLORIDE
Applicant:	Micro Labs
Ingredient:	proparacaine hydrochloride
Patents:	0

Pharmacology for NDA: 219294

Physiological Effect	Local Anesthesia

Suppliers and Packaging for NDA: 219294

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PROPARACAINE HYDROCHLORIDE	proparacaine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	219294	ANDA	Micro Labs Limited	42571-497	42571-497-57	1 BOTTLE in 1 CARTON (42571-497-57) / 15 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	0.5%
Approval Date:	Oct 20, 2025	TE:	AT	RLD:	No

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