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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050819
Company: BAUSCH

Summary Review

Products on NDA 050819

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ACANYA	BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE	2.5%;EQ 1.2% BASE	GEL;TOPICAL	Prescription	AB	Yes	Yes
ONEXTON	BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE	3.75%;EQ 1.2% BASE	GEL;TOPICAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050819

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/23/2008	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050819lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050819s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/050819_acanya_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/050819s000_SumR_P1.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/21/2020	SUPPL-24	Labeling-Patient Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050819s023s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/050819Orig1s023, s024ltr.pdf
02/21/2020	SUPPL-23	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050819s023s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/050819Orig1s023, s024ltr.pdf
03/25/2016	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
10/08/2015	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
11/19/2015	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
09/10/2015	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
11/24/2014	SUPPL-12	Efficacy-New Dosing Regimen	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050819s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050819Orig1s012ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/050819Orig1s012.pdf
03/18/2014	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
02/28/2014	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050819s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050819Orig1s010ltr.pdf
12/18/2012	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
10/18/2010	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050819s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050819s003ltr.pdf
06/23/2010	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050819s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050819s002ltr.pdf

Labels for NDA 050819

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/21/2020	SUPPL-24	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050819s023s024lbl.pdf
02/21/2020	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050819s023s024lbl.pdf
02/21/2020	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050819s023s024lbl.pdf
02/21/2020	SUPPL-23	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050819s023s024lbl.pdf
11/24/2014	SUPPL-12	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050819s012lbl.pdf
02/28/2014	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050819s010lbl.pdf
10/18/2010	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050819s003lbl.pdf
06/23/2010	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050819s002lbl.pdf
10/23/2008	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050819lbl.pdf

Therapeutic Equivalents for NDA 050819

ACANYA

GEL;TOPICAL; 2.5%;EQ 1.2% BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ACANYA	BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE	2.5%;EQ 1.2% BASE	GEL;TOPICAL	Prescription	Yes	AB	050819	BAUSCH
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE	2.5%;EQ 1.2% BASE	GEL;TOPICAL	Prescription	No	AB	205128	ACTAVIS LABS UT INC
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE	2.5%;EQ 1.2% BASE	GEL;TOPICAL	Prescription	No	AB	205397	PADAGIS ISRAEL
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE	2.5%;EQ 1.2% BASE	GEL;TOPICAL	Prescription	No	AB	206575	TARO

ONEXTON

GEL;TOPICAL; 3.75%;EQ 1.2% BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE	3.75%;EQ 1.2% BASE	GEL;TOPICAL	Prescription	No	AB	208683	TARO
ONEXTON	BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE	3.75%;EQ 1.2% BASE	GEL;TOPICAL	Prescription	Yes	AB	050819	BAUSCH

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