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01 2Alcon Inc

02 1Amneal Pharmaceuticals

03 14Bausch & Lomb Incorporated

04 2Biodeal Pharmaceuticals

05 1Hikma Pharmaceuticals

06 2Indiana Ophthalmics

07 1Indoco Remedies Limited

08 1Laboratorios Poen

09 2Lupin Ltd

10 2Padagis

11 1Pharmos

12 3Sentiss Pharma

13 2Sun Pharmaceutical Industries Limited

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PharmaCompass

01

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
Not Confirmed

LOTEPREDNOL ETABONATE

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

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02

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
Not Confirmed

LOTEPREDNOL ETABONATE

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

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03

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
Not Confirmed

LOTEPREDNOL ETABONATE

Brand Name : LOTEPREDNOL ETABONATE

Dosage Form : SUSPENSION/DROPS;OPHTHALMIC

Dosage Strength : 0.2%

Packaging :

Approval Date : 2024-12-13

Application Number : 216345

Regulatory Info : RX

Registration Country : USA

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04

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
Not Confirmed

LOTEPREDNOL ETABONATE

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

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05

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
Not Confirmed

LOTEPREDNOL ETABONATE

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

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06

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
Not Confirmed

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

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07

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
Not Confirmed

LOTEPREDNOL ETABONATE

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

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08

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
Not Confirmed

LOTEPREDNOL ETABONATE

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

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09

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
Not Confirmed

LOTEPREDNOL ETABONATE

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

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10

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
Not Confirmed

LOTEPREDNOL ETABONATE

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

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11

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
Not Confirmed

LOTEPREDNOL ETABONATE

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

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12

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
Not Confirmed

LOTEPREDNOL ETABONATE

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

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13

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
Not Confirmed

LOTEPREDNOL ETABONATE

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

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14

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
Not Confirmed

LOTEPREDNOL ETABONATE

Brand Name : LOTEPREDNOL ETABONATE

Dosage Form : SUSPENSION/DROPS;OPHTHALMIC

Dosage Strength : 0.5%

Packaging :

Approval Date : 2025-01-29

Application Number : 215204

Regulatory Info : RX

Registration Country : USA

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15

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
Not Confirmed

LOTEPREDNOL ETABONATE

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

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16

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
Not Confirmed

LOTEPREDNOL ETABONATE

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

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17

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
Not Confirmed

LOTEPREDNOL ETABONATE

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

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18

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
Not Confirmed

LOTEPREDNOL ETABONATE

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

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19

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
Not Confirmed

LOTEPREDNOL ETABONATE

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

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20

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
Not Confirmed

LOTEPREDNOL ETABONATE

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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