Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050769
Company: CUTANEA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AKTIPAK BENZOYL PEROXIDE; ERYTHROMYCIN 5%;3% 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
11/27/2000 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-769_Benamycin.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/29/2016 SUPPL-17 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050769s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050769Orig1s017ltr.pdf
03/16/2015 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

11/01/2002 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

08/28/2002 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

10/23/2002 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

09/03/2002 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

10/17/2001 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/17/2001 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

06/29/2001 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

03/22/2001 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
09/29/2016 SUPPL-17 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050769s017lbl.pdf

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