Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 050819
Company: DOW PHARM
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 None Yes Yes
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
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)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050819s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050819Orig1s012ltr.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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

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 DOW PHARM
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

ONEXTON

There are no Therapeutic Equivalents.

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English