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Details for New Drug Application (NDA): 020583

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NDA 020583 describes LOTEMAX, which is a drug marketed by Bausch And Lomb, Pharmos, and Bausch And Lomb Inc, and is included in four NDAs. It is available from two suppliers. There is one patent protecting this drug. Additional details are available on the LOTEMAX profile page.

The generic ingredient in LOTEMAX is loteprednol etabonate. There are nine drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the loteprednol etabonate profile page.

Summary for NDA: 020583

Tradename:
LOTEMAX
Applicant:
Bausch And Lomb
Ingredient:
loteprednol etabonate
Patents:0
Therapeutic Class:Ophthalmic Agents

Pharmacology for NDA: 020583

Suppliers and Packaging for NDA: 020583

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LOTEMAX
loteprednol etabonate
SUSPENSION/DROPS;OPHTHALMIC 020583 NDA Bausch & Lomb Incorporated 24208-299 24208-299-05 1 BOTTLE in 1 CARTON (24208-299-05) > 5 mL in 1 BOTTLE
LOTEMAX
loteprednol etabonate
SUSPENSION/DROPS;OPHTHALMIC 020583 NDA Bausch & Lomb Incorporated 24208-299 24208-299-10 1 BOTTLE in 1 CARTON (24208-299-10) > 10 mL in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION/DROPS;OPHTHALMICStrength0.5%
Approval Date:Mar 9, 1998TE:RLD:Yes

Expired Orange Book Patents for NDA: 020583

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bausch And Lomb
LOTEMAX
loteprednol etabonate
SUSPENSION/DROPS;OPHTHALMIC020583-001Mar 9, 19984,996,335*PED► subscribe
Bausch And Lomb
LOTEMAX
loteprednol etabonate
SUSPENSION/DROPS;OPHTHALMIC020583-001Mar 9, 19985,747,061*PED► subscribe
Bausch And Lomb
LOTEMAX
loteprednol etabonate
SUSPENSION/DROPS;OPHTHALMIC020583-001Mar 9, 19985,540,930*PED► subscribe
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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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