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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 040075


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NDA 040075 describes PENTOLAIR, which is a drug marketed by Bausch And Lomb and Pharmafair and is included in three NDAs. It is available from one supplier. Additional details are available on the PENTOLAIR profile page.

The generic ingredient in PENTOLAIR is cyclopentolate hydrochloride. There are two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the cyclopentolate hydrochloride profile page.
Summary for 040075
Tradename:PENTOLAIR
Applicant:Bausch And Lomb
Ingredient:cyclopentolate hydrochloride
Patents:0
Medical Subject Heading (MeSH) Categories for 040075
Suppliers and Packaging for NDA: 040075
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PENTOLAIR cyclopentolate hydrochloride SOLUTION/DROPS;OPHTHALMIC 040075 ANDA Bausch & Lomb Incorporated 24208-735 24208-735-01 1 BOTTLE, DROPPER in 1 CARTON (24208-735-01) / 2 mL in 1 BOTTLE, DROPPER
PENTOLAIR cyclopentolate hydrochloride SOLUTION/DROPS;OPHTHALMIC 040075 ANDA Bausch & Lomb Incorporated 24208-735 24208-735-06 1 BOTTLE, DROPPER in 1 CARTON (24208-735-06) / 15 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength1%
Approval Date:Apr 29, 1994TE:ATRLD:No

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