Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050793
Company: PERRIGO PHARMA INTL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLINDESSE CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM;VAGINAL 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
11/30/2004 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/050793lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/050793ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/050793s000_ClinesseTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/18/2017 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

03/01/2016 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

02/11/2016 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

09/22/2014 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

04/09/2013 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

01/16/2013 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

02/15/2012 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050793s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050793s015ltr.pdf
12/15/2010 SUPPL-14 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050793s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050793s014ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/15/2012 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050793s015lbl.pdf
12/15/2010 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050793s014lbl.pdf
11/30/2004 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/050793lbl.pdf

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