Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050805
Company: GALDERMA LABS LP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ORACEA DOXYCYCLINE 40MG CAPSULE;ORAL 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
05/26/2006 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050805lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050805s000LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/050805s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/03/2015 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

06/24/2015 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

07/25/2013 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050805s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050805Orig1s008ltr.pdf
11/07/2012 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050805s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050805Orig1s007ltr.pdf
05/13/2010 SUPPL-2 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050805s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050805s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/25/2013 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050805s008lbl.pdf
11/07/2012 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050805s007lbl.pdf
05/13/2010 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050805s002lbl.pdf
05/26/2006 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050805lbl.pdf

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