Dapsone | FDA Orange Book | Approved Drug Product List

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Medlab Asia & Asia Health

Not Confirmed

U.S.A

RLD : Yes

TE Code : AB

DAPSONE

Brand Name : ACZONE

Dosage Form : GEL;TOPICAL

Dosage Strength : 5%

Approval Date : 2005-07-07

Application Number : 21794

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

Product Web Link

Corporate PDF

02

TARO

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Medlab Asia & Asia Health

Not Confirmed

U.S.A

RLD : No

TE Code :

DAPSONE

Brand Name : DAPSONE

Dosage Form : TABLET;ORAL

Dosage Strength : 25MG

Approval Date : 2019-03-01

Application Number : 209430

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Portfolio PDF

Product Web Link

Corporate PDF

03

TARO

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Medlab Asia & Asia Health

Not Confirmed

U.S.A

RLD : No

TE Code :

DAPSONE

Brand Name : DAPSONE

Dosage Form : TABLET;ORAL

Dosage Strength : 100MG

Approval Date : 2019-03-01

Application Number : 209430

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Portfolio PDF

Product Web Link

Corporate PDF

04

TARO

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Medlab Asia & Asia Health

Not Confirmed

U.S.A

RLD : No

TE Code : AB

DAPSONE

Brand Name : DAPSONE

Dosage Form : GEL;TOPICAL

Dosage Strength : 5%

Approval Date : 2017-10-16

Application Number : 209506

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

Product Web Link

Corporate PDF

05

TARO

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Medlab Asia & Asia Health

Not Confirmed

U.S.A

RLD : No

TE Code : AB

DAPSONE

Brand Name : DAPSONE

Dosage Form : GEL;TOPICAL

Dosage Strength : 7.5%

Approval Date : 2019-06-26

Application Number : 210191

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

Product Web Link

Corporate PDF

06

CHARTWELL RX

Medlab Asia & Asia Health

Not Confirmed

07

NOSTRUM LABS INC

Medlab Asia & Asia Health

Not Confirmed

08

NOSTRUM LABS INC