01 2Alcon Inc
02 1Amneal Pharmaceuticals
03 13Bausch & Lomb Incorporated
04 1Hikma Pharmaceuticals
05 2Indiana Ophthalmics
06 1Indoco Remedies Limited
07 1Laboratorios Poen
08 2Lupin Ltd
09 1Padagis
10 1Pharmos
11 3Sentiss Pharma
12 2Sun Pharmaceutical Industries Limited
01 1GEL
02 5GEL;OPHTHALMIC
03 1OINTMENT
04 1OINTMENT;OPHTHALMIC
05 2OPD
06 1Ophthalmic Ointment
07 2Ophthalmic Suspension
08 2SUSPENSION
09 13SUSPENSION/DROPS;OPHTHALMIC
10 1Suspension
11 1Blank
01 2DISCN
02 1Generic
03 2Originator
04 16RX
05 9Blank
01 2ALREX
02 1Alrex
03 1EYSUVIS
04 1INVELTYS
05 5LOTEMAX
06 1LOTEMAX GEL
07 1LOTEMAX OINTMENT
08 1LOTEMAX SM
09 10LOTEPREDNOL ETABONATE
10 1Lotemax
11 1Lotemax Ophthalmic Suspension
12 1Lotesoft
13 1ZYLET
14 3Blank
01 1Argentina
02 4Canada
03 3India
04 1Italy
05 2South Africa
06 19USA
Regulatory Info : RX
Registration Country : USA
Brand Name : INVELTYS
Dosage Form : SUSPENSION/DROPS;OPHTHALMIC
Dosage Strength : 1%
Packaging :
Approval Date : 2018-08-22
Application Number : 210565
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : EYSUVIS
Dosage Form : SUSPENSION/DROPS;OPHTHALMIC
Dosage Strength : 0.25%
Packaging :
Approval Date : 2020-10-26
Application Number : 210933
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : LOTEPREDNOL ETABONATE
Dosage Form : SUSPENSION/DROPS;OPHTHALMIC
Dosage Strength : 0.2%
Packaging :
Approval Date :
Application Number : 216345
Regulatory Info :
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : LOTEMAX
Dosage Form : SUSPENSION/DROPS;OPHTHALMIC
Dosage Strength : 0.5%
Packaging :
Approval Date : 1998-03-09
Application Number : 20583
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ALREX
Dosage Form : SUSPENSION/DROPS;OPHTHALMIC
Dosage Strength : 0.2%
Packaging :
Approval Date : 1998-03-09
Application Number : 20803
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
LOTEPREDNOL ETABONATE; TOBRAMYCIN
Brand Name : ZYLET
Dosage Form : SUSPENSION/DROPS;OPHTHALMIC
Dosage Strength : 0.5%;0.3%
Packaging :
Approval Date : 2004-12-14
Application Number : 50804
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : LOTEMAX
Dosage Form : OINTMENT;OPHTHALMIC
Dosage Strength : 0.5%
Packaging :
Approval Date : 2011-04-15
Application Number : 200738
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : LOTEMAX
Dosage Form : GEL;OPHTHALMIC
Dosage Strength : 0.5%
Packaging :
Approval Date : 2012-09-28
Application Number : 202872
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : LOTEMAX SM
Dosage Form : GEL;OPHTHALMIC
Dosage Strength : 0.38%
Packaging :
Approval Date : 2019-02-22
Application Number : 208219
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : Italy
Brand Name : Lotemax
Dosage Form :
Dosage Strength : Coll 5 Ml 0.5%
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Canada
Brand Name : LOTEMAX
Dosage Form : SUSPENSION
Dosage Strength : 0.5%/W/V
Packaging : 5ML/10ML
Approval Date :
Application Number : 2321114
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : ALREX
Dosage Form : SUSPENSION
Dosage Strength : 0.2%/W/V
Packaging : 5ML
Approval Date :
Application Number : 2320924
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : LOTEMAX GEL
Dosage Form : GEL
Dosage Strength : 0.5%/W/W
Packaging : 5G IN 10ML BOTTLE
Approval Date :
Application Number : 2435853
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : LOTEMAX OINTMENT
Dosage Form : OINTMENT
Dosage Strength : 0.5%/W/W
Packaging : 1/3.5G
Approval Date :
Application Number : 2421941
Regulatory Info :
Registration Country : Canada
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Lotemax Ophthalmic Suspension
Dosage Form : OPD
Dosage Strength : 5mg/ml
Packaging : 5X1mg/ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Alrex
Dosage Form : OPD
Dosage Strength : 2mg/ml
Packaging : 5X1mg/ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : DISCN
Registration Country : USA
Brand Name : LOTEPREDNOL ETABONATE
Dosage Form : GEL;OPHTHALMIC
Dosage Strength : 0.5%
Packaging :
Approval Date : 2023-11-29
Application Number : 213956
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Ophthalmic Ointment
Dosage Strength : 0.5%/W/W
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Ophthalmic Suspension
Dosage Strength : 0.2%
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info : Generic
Registration Country : India
Brand Name :
Dosage Form : Suspension
Dosage Strength : 0.5%
Packaging : 5/10/15ml
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : India
Regulatory Info :
Registration Country : Argentina
Brand Name : Lotesoft
Dosage Form : Ophthalmic Suspension
Dosage Strength : 0.5%
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Argentina
Regulatory Info : RX
Registration Country : USA
Brand Name : LOTEPREDNOL ETABONATE
Dosage Form : SUSPENSION/DROPS;OPHTHALMIC
Dosage Strength : 0.2%
Packaging :
Approval Date : 2023-12-26
Application Number : 215550
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : LOTEPREDNOL ETABONATE
Dosage Form : SUSPENSION/DROPS;OPHTHALMIC
Dosage Strength : 0.5%
Packaging :
Approval Date : 2024-04-24
Application Number : 215719
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : LOTEPREDNOL ETABONATE
Dosage Form : SUSPENSION/DROPS;OPHTHALMIC
Dosage Strength : 0.2%
Packaging :
Approval Date : 2024-07-10
Application Number : 215203
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : LOTEMAX
Dosage Form : SUSPENSION/DROPS;OPHTHALMIC
Dosage Strength : 0.5%
Packaging :
Approval Date : 1998-03-09
Application Number : 20841
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : LOTEPREDNOL ETABONATE
Dosage Form : SUSPENSION/DROPS;OPHTHALMIC
Dosage Strength : 0.5%
Packaging :
Approval Date : 2019-04-17
Application Number : 207609
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : LOTEPREDNOL ETABONATE
Dosage Form : GEL;OPHTHALMIC
Dosage Strength : 0.5%
Packaging :
Approval Date : 2021-02-10
Application Number : 212080
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : LOTEPREDNOL ETABONATE
Dosage Form : SUSPENSION/DROPS;OPHTHALMIC
Dosage Strength : 0.2%
Packaging :
Approval Date : 2023-04-12
Application Number : 215933
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : LOTEPREDNOL ETABONATE
Dosage Form : SUSPENSION/DROPS;OPHTHALMIC
Dosage Strength : 0.5%
Packaging :
Approval Date : 2021-02-26
Application Number : 212450
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : LOTEPREDNOL ETABONATE
Dosage Form : GEL;OPHTHALMIC
Dosage Strength : 0.5%
Packaging :
Approval Date : 2023-08-09
Application Number : 215384
Regulatory Info : RX
Registration Country : USA
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