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Details for New Drug Application (NDA): 040075

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NDA 040075 describes PENTOLAIR, which is a drug marketed by Pharmafair and Bausch And Lomb and is included in three NDAs. It is available from three suppliers. 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. Seven suppliers are listed for this compound. Additional details are available on the cyclopentolate hydrochloride profile page.

Summary for NDA: 040075

Tradename:
PENTOLAIR
Applicant:
Bausch And Lomb
Ingredient:
cyclopentolate hydrochloride
Patents:0
Formulation / Manufacturing:see details

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

Summary for product number 001

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


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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