Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050756
Company: BAUSCH
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 Prescription AB Yes Yes
BENZACLIN BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE 5%;EQ 1% BASE GEL;TOPICAL Discontinued None No No
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.cfm
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.

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

BENZACLIN

GEL;TOPICAL; 5%;EQ 1% BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BENZACLIN BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE 5%;EQ 1% BASE GEL;TOPICAL Prescription Yes AB 050756 BAUSCH
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE 5%;EQ 1% BASE GEL;TOPICAL Prescription No AB 209252 GLENMARK PHARMS
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE 5%;EQ 1% BASE GEL;TOPICAL Prescription No AB 065443 MYLAN PHARMS INC
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE 5%;EQ 1% BASE GEL;TOPICAL Prescription No AB 202440 PERRIGO UK FINCO
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE 5%;EQ 1% BASE GEL;TOPICAL Prescription No AB 208776 TARO
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE 5%;EQ 1% BASE GEL;TOPICAL Prescription No AB 204087 TOLMAR

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