Benzoyl Peroxide | FDA Orange Book | Approved Drug Product List

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American Pharma Summit

Not Confirmed

U.S.A

RLD : No

TE Code : AB

Brand Name : CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE

Dosage Form : GEL;TOPICAL

Dosage Strength : 5%;1.2%

Approval Date : 2017-12-15

Application Number : 206218

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

Product Web Link

Corporate PDF

02

TARO

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American Pharma Summit

Not Confirmed

U.S.A

RLD : No

TE Code : AB

Brand Name : CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE

Dosage Form : GEL;TOPICAL

Dosage Strength : 2.5%;EQ 1.2% BASE

Approval Date : 2019-08-19

Application Number : 206575

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

Product Web Link

Corporate PDF

03

TARO

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American Pharma Summit

Not Confirmed

U.S.A

RLD : No

TE Code : AB

ADAPALENE; BENZOYL PEROXIDE

Brand Name : ADAPALENE AND BENZOYL PEROXIDE

Dosage Form : GEL;TOPICAL

Dosage Strength : 0.1%;2.5%

Approval Date : 2018-01-24

Application Number : 206959

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

Product Web Link

Corporate PDF

04

TARO

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American Pharma Summit

Not Confirmed

U.S.A

RLD : No

TE Code : AB

Brand Name : CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE

Dosage Form : GEL;TOPICAL

Dosage Strength : 3.75%;EQ 1.2% BASE

Approval Date : 2018-06-05

Application Number : 208683

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

Product Web Link

Corporate PDF

05

TARO

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American Pharma Summit

Not Confirmed

U.S.A

RLD : No

TE Code : AB

Brand Name : CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE

Dosage Form : GEL;TOPICAL

Dosage Strength : 5%;EQ 1% BASE

Approval Date : 2018-05-25

Application Number : 208776

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

Product Web Link

Corporate PDF

06

TARO

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American Pharma Summit

Not Confirmed

U.S.A

RLD : No

TE Code : AB

ADAPALENE; BENZOYL PEROXIDE

Brand Name : ADAPALENE AND BENZOYL PEROXIDE

Dosage Form : GEL;TOPICAL

Dosage Strength : 0.3%;2.5%

Approval Date : 2018-10-17

Application Number : 209148

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

Product Web Link

Corporate PDF

07

BAUSCH

Canada

American Pharma Summit

Not Confirmed

08

VALEANT INTL

Canada

American Pharma Summit

Not Confirmed

09

GALDERMA LABS LP