Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050781
Company: ORAPHARMA
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 |
---|---|---|---|---|---|
05/24/2024 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050781s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/050781Orig1s025ltr.pdf | |
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 |
---|---|---|---|---|---|
05/24/2024 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050781s025lbl.pdf | |
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 |