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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050781
Company: ORAPHARMA

Products on NDA 050781

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050781

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.

Labels for NDA 050781

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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