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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Express Scripts
Federal Trade Commission
Farmers Insurance
Chinese Patent Office

Generated: January 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040074

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NDA 040074 describes PROPARACAINE HYDROCHLORIDE, which is a drug marketed by Akorn Inc, Bausch And Lomb, and Sola Barnes Hind, and is included in four 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 040074
Applicant:Bausch And Lomb
Ingredient:proparacaine hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 040074
Physiological EffectLocal 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 Rebel Distributors Corp 21695-530 21695-530-15 15 mL in 1 BOTTLE, DROPPER (21695-530-15)
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

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.5%
Approval Date:Sep 29, 1995TE:ATRLD:No

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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Johnson and Johnson
Boehringer Ingelheim

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