Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050781
Company: ORAPHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ARESTIN MINOCYCLINE HYDROCHLORIDE EQ 1MG BASE POWDER, EXTENDED RELEASE;DENTAL 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
02/16/2001 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50781lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/50781_Arestin.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/08/2017 SUPPL-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050781s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050781Orig1s020ltr.pdf
07/27/2012 SUPPL-19 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050781s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050781Orig1s019ltr.pdf
02/15/2008 SUPPL-12 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050781s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050781s012ltr.pdf
02/15/2008 SUPPL-11 Labeling-Container/Carton Labels

Label is not available on this site.

01/28/2002 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

10/12/2001 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

09/14/2001 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

08/14/2001 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

08/14/2001 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

07/13/2001 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/08/2017 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050781s020lbl.pdf
07/27/2012 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050781s019lbl.pdf
02/15/2008 SUPPL-12 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050781s012lbl.pdf
02/16/2001 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50781lbl.pdf

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