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Approved Drug Products containing Loteprednol listed in the FDA Orange Book. Original Data : FDA Website

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01 2ALCON LABS INC

02 4BAUSCH AND LOMB

03 2BAUSCH AND LOMB INC

04 1HIKMA

05 2LUPIN LTD

06 1PADAGIS US

07 1PHARMOS

08 3SENTISS

09 2SUN PHARM

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PharmaCompass

01

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LOTEPREDNOL ETABONATE

Brand Name : INVELTYS

Dosage Form : SUSPENSION/DROPS;OPHTHALMIC

Dosage Strength : 1%

Approval Date : 2018-08-22

Application Number : 210565

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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02

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LOTEPREDNOL ETABONATE

Brand Name : EYSUVIS

Dosage Form : SUSPENSION/DROPS;OPHTHALMIC

Dosage Strength : 0.25%

Approval Date : 2020-10-26

Application Number : 210933

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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03

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LOTEPREDNOL ETABONATE

Brand Name : LOTEMAX

Dosage Form : SUSPENSION/DROPS;OPHTHALMIC

Dosage Strength : 0.5%

Approval Date : 1998-03-09

Application Number : 20583

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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04

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LOTEPREDNOL ETABONATE

Brand Name : ALREX

Dosage Form : SUSPENSION/DROPS;OPHTHALMIC

Dosage Strength : 0.2%

Approval Date : 1998-03-09

Application Number : 20803

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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05

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LOTEPREDNOL ETABONATE; TOBRAMYCIN

Brand Name : ZYLET

Dosage Form : SUSPENSION/DROPS;OPHTHALMIC

Dosage Strength : 0.5%;0.3%

Approval Date : 2004-12-14

Application Number : 50804

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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06

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LOTEPREDNOL ETABONATE

Brand Name : LOTEMAX

Dosage Form : OINTMENT;OPHTHALMIC

Dosage Strength : 0.5%

Approval Date : 2011-04-15

Application Number : 200738

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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07

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LOTEPREDNOL ETABONATE

Brand Name : LOTEMAX

Dosage Form : GEL;OPHTHALMIC

Dosage Strength : 0.5%

Approval Date : 2012-09-28

Application Number : 202872

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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08

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LOTEPREDNOL ETABONATE

Brand Name : LOTEMAX SM

Dosage Form : GEL;OPHTHALMIC

Dosage Strength : 0.38%

Approval Date : 2019-02-22

Application Number : 208219

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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09

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LOTEPREDNOL ETABONATE

Brand Name : LOTEMAX

Dosage Form : SUSPENSION/DROPS;OPHTHALMIC

Dosage Strength : 0.5%

Approval Date : 1998-03-09

Application Number : 20841

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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10

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LOTEPREDNOL ETABONATE

Brand Name : LOTEPREDNOL ETABONATE

Dosage Form : SUSPENSION/DROPS;OPHTHALMIC

Dosage Strength : 0.5%

Approval Date : 2019-04-17

Application Number : 207609

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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