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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050756
Company: BAUSCH

Products on NDA 050756

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BENZACLIN	BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE	5%;EQ 1% BASE	GEL;TOPICAL	Discontinued	None	Yes	No
BENZACLIN	BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE	5%;EQ 1% BASE	GEL;TOPICAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050756

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/21/2000	ORIG-1	Approval	Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-756_Benzaclin_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-756_Benzaclin_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-756_Benzaclin.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/05/2014	SUPPL-44	Manufacturing (CMC)		Label is not available on this site.
09/22/2014	SUPPL-43	Manufacturing (CMC)		Label is not available on this site.
03/02/2011	SUPPL-40	Manufacturing (CMC)	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050756s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050756s040ltr.pdf
06/17/2010	SUPPL-37	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050756s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050756s037ltr.pdf
06/14/2010	SUPPL-35	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
06/12/2009	SUPPL-34	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050756s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050756s034ltr.pdf
04/20/2007	SUPPL-27	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050756s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050756s027ltr.pdf
05/23/2007	SUPPL-26	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050756s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050756s026ltr.pdf
04/28/2005	SUPPL-16	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050756s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050756s016ltr.pdf
08/28/2002	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
06/27/2002	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
08/09/2002	SUPPL-7	Manufacturing (CMC)-Packaging	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50756s7lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50756scp007ltr.pdf
03/26/2002	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
09/26/2001	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
09/25/2001	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
10/12/2001	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
08/30/2001	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
04/17/2001	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 050756

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/02/2011	SUPPL-40	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050756s040lbl.pdf
06/17/2010	SUPPL-37	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050756s037lbl.pdf
06/12/2009	SUPPL-34	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050756s034lbl.pdf
05/23/2007	SUPPL-26	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050756s026lbl.pdf
04/20/2007	SUPPL-27	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050756s027lbl.pdf
04/28/2005	SUPPL-16	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050756s016lbl.pdf
08/09/2002	SUPPL-7	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50756s7lbl.pdf
12/21/2000	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-756_Benzaclin_prntlbl.pdf

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