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

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01

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Discovery on Target
Not Confirmed

TAVABOROLE

Brand Name : TAVABOROLE

Dosage Form : SOLUTION;TOPICAL

Dosage Strength : 5%

Approval Date : 2021-05-07

Application Number : 212215

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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02

Luxepack
Not Confirmed
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03

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

TAVABOROLE

Brand Name : TAVABOROLE

Dosage Form : SOLUTION;TOPICAL

Dosage Strength : 5%

Approval Date : 2020-11-25

Application Number : 212256

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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04

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

TAVABOROLE

Brand Name : TAVABOROLE

Dosage Form : SOLUTION;TOPICAL

Dosage Strength : 5%

Approval Date : 2021-02-03

Application Number : 211963

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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05

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

TAVABOROLE

Brand Name : TAVABOROLE

Dosage Form : SOLUTION;TOPICAL

Dosage Strength : 5%

Approval Date : 2021-02-09

Application Number : 212224

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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06

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

TAVABOROLE

Brand Name : TAVABOROLE

Dosage Form : SOLUTION;TOPICAL

Dosage Strength : 5%

Approval Date : 2020-10-13

Application Number : 211297

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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07

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

TAVABOROLE

Brand Name : TAVABOROLE

Dosage Form : SOLUTION;TOPICAL

Dosage Strength : 5%

Approval Date : 2021-02-08

Application Number : 212168

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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08

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

TAVABOROLE

Brand Name : TAVABOROLE

Dosage Form : SOLUTION;TOPICAL

Dosage Strength : 5%

Approval Date : 2020-10-13

Application Number : 211848

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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09

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

TAVABOROLE

Brand Name : KERYDIN

Dosage Form : SOLUTION;TOPICAL

Dosage Strength : 5%

Approval Date : 2014-07-07

Application Number : 204427

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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10

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

TAVABOROLE

Brand Name : TAVABOROLE

Dosage Form : SOLUTION;TOPICAL

Dosage Strength : 5%

Approval Date : 2023-04-10

Application Number : 212294

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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