Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050756
Company: BAUSCH
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 | Discontinued | None | Yes | No |
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-Container/Carton Labels, Labeling-Package Insert |
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 |