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 |
| 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 |