Details for New Drug Application (NDA): 202872

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NDA 202872 describes LOTEMAX, which is a drug marketed by Bausch And Lomb Inc, Bausch And Lomb, and Pharmos, and is included in five NDAs. It is available from four suppliers. There are two patents protecting this drug. Additional details are available on the LOTEMAX profile page.

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

Summary for 202872

Tradename:	LOTEMAX
Applicant:	Bausch And Lomb Inc
Ingredient:	loteprednol etabonate
Patents:	0

Pharmacology for NDA: 202872

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 202872

Anti-Allergic Agents

Suppliers and Packaging for NDA: 202872

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LOTEMAX	loteprednol etabonate	GEL;OPHTHALMIC	202872	NDA	Bausch & Lomb Incorporated	24208-503	24208-503-07	1 BOTTLE in 1 CARTON (24208-503-07) / 5 g in 1 BOTTLE
LOTEMAX	loteprednol etabonate	GEL;OPHTHALMIC	202872	NDA	Bausch & Lomb Incorporated	24208-503	24208-503-48	1 BOTTLE in 1 CARTON (24208-503-48) / .5 g in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;OPHTHALMIC			Strength	0.5%
Approval Date:	Sep 28, 2012	TE:	AB	RLD:	Yes

Expired US Patents for NDA 202872

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch And Lomb Inc	LOTEMAX	loteprednol etabonate	GEL;OPHTHALMIC	202872-001	Sep 28, 2012	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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