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FDA Orange Book · active-ingredient family

Benzoyl peroxide; clindamycin phosphate

Benzoyl peroxide; clindamycin phosphate is approved as 3 brand and 16 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ACANYA · NDA 050819

3

Brand (NDA)

16

Generics (ANDA)

9

Listed patents

0

Exclusivity periods

Brand (NDA) products · gel

ProductApplicantApplicationTEApproved
ACANYARLD×2BAUSCHNDA 050819ABOct 23, 2008
DUACRLDSTIEFELNDA 050741ABAug 26, 2002
BENZACLINRLD×2BAUSCHNDA 050756—Dec 21, 2000

Generic (ANDA) products (16)

ProductApplicantApplicationTEApproved
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDEPADAGIS ISRAELANDA 209610ABAug 20, 2024
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDEENCUBEANDA 212433ABApr 28, 2021
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDEPADAGIS ISRAELANDA 205397ABSep 09, 2019
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDEENCUBEANDA 207194ABAug 19, 2019
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDESUN PHARMA CANADAANDA 206575ABAug 19, 2019
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDEGLENMARK SPECLTANDA 209252ABMar 14, 2019
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDEZYDUS PHARMSANDA 210794ABDec 28, 2018
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDESUN PHARMA CANADAANDA 208683ABJun 05, 2018
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDESUN PHARMA CANADAANDA 208776ABMay 25, 2018
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDESUN PHARMA CANADAANDA 206218ABDec 15, 2017
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDEENCUBEANDA 204087ABJun 27, 2017
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDECHARTWELL RXANDA 203688—Aug 25, 2016
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDEPADAGIS ISRAELANDA 202440ABSep 21, 2015
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDEACTAVIS LABS UT INCANDA 205128ABJun 19, 2015
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDEPADAGIS ISRAELANDA 090979ABJun 26, 2012
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDEMYLAN PHARMS INCANDA 065443ABAug 11, 2009

Listed patents (9)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8895070Jun 03, 2029in 3 yr
U-124
10220049Jun 03, 2029in 3 yr
ProductU-916
10624918Jun 03, 2029in 3 yr
U-916
8663699Jun 03, 2029in 3 yr
U-124
9078870Jun 03, 2029in 3 yr
Product
9561208Jun 03, 2029in 3 yr
ProductU-916
9504704Jun 03, 2029in 3 yr
ProductU-134
10137142Jun 03, 2029in 3 yr
ProductU-916
8288434Aug 05, 2029in 3 yr 2 mo
ProductU-124

Benzoyl peroxide; clindamycin phosphate — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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