Details for New Drug Application (NDA): 040074

NDA 040074 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 six 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. Nine suppliers are listed for this compound. Additional details are available on the proparacaine hydrochloride profile page.

Summary for 040074

Tradename:	PROPARACAINE HYDROCHLORIDE
Applicant:	Bausch And Lomb
Ingredient:	proparacaine hydrochloride
Patents:	0

Pharmacology for NDA: 040074

Physiological Effect

Local Anesthesia

Suppliers and Packaging for NDA: 040074

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PROPARACAINE HYDROCHLORIDE	proparacaine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	040074	ANDA	Bausch & Lomb Incorporated	24208-730	24208-730-06	1 BOTTLE, DROPPER in 1 CARTON (24208-730-06) / 15 mL in 1 BOTTLE, DROPPER
PROPARACAINE HYDROCHLORIDE	proparacaine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	040074	ANDA	A-S Medication Solutions	50090-1923	50090-1923-0	1 BOTTLE, DROPPER in 1 CARTON (50090-1923-0) / 15 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	0.5%
Approval Date:	Sep 29, 1995	TE:	AT	RLD:	No

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