Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050795
Company: MAYNE PHARMA
Company: MAYNE PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DORYX | DOXYCYCLINE HYCLATE | EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE;ORAL | Discontinued | None | Yes | No |
| DORYX | DOXYCYCLINE HYCLATE | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE;ORAL | Discontinued | None | Yes | No |
| DORYX | DOXYCYCLINE HYCLATE | EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE;ORAL | Discontinued | None | Yes | No |
| DORYX | DOXYCYCLINE HYCLATE | EQ 80MG BASE | TABLET, DELAYED RELEASE;ORAL | Discontinued | None | Yes | No |
| DORYX | DOXYCYCLINE HYCLATE | EQ 200MG BASE | TABLET, DELAYED RELEASE;ORAL | Discontinued | None | Yes | No |
| DORYX | DOXYCYCLINE HYCLATE | EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE;ORAL | Discontinued | None | Yes | No |
| DORYX MPC | DOXYCYCLINE HYCLATE | EQ 60MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | AB | Yes | No |
| DORYX MPC | DOXYCYCLINE HYCLATE | EQ 120MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE;ORAL | Discontinued | None | Yes | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/31/2025 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/050795s037lbl.pdf | |
| 07/15/2024 | SUPPL-36 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050795Orig1s036lbl.pdf | |
| 07/25/2022 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050795s030lbl.pdf | |
| 02/12/2020 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050795s028lbl.pdf | |
| 02/07/2018 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050795s026lbl.pdf | |
| 05/31/2017 | SUPPL-24 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050795s024lbl.pdf |
| 05/20/2016 | SUPPL-22 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050795s022lbl.pdf | |
| 05/18/2016 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050795s021lbl.pdf | |
| 05/18/2016 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050795s021lbl.pdf | |
| 05/18/2016 | SUPPL-21 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050795s021lbl.pdf | |
| 06/04/2015 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050795s018lbl.pdf | |
| 03/04/2015 | SUPPL-20 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050795Orig1s020lbl.pdf | |
| 12/19/2014 | SUPPL-19 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050795Orig1s019lbl.pdf |
| 04/11/2013 | SUPPL-10 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050795s010lbl.pdf | |
| 09/13/2011 | SUPPL-14 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050795s014lbl.pdf |
| 03/21/2011 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050795s013lbl.pdf | |
| 06/20/2008 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050795s005lbl.pdf | |
| 06/20/2008 | SUPPL-5 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050795s005lbl.pdf | |
| 12/18/2007 | SUPPL-3 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050795s003lbl.pdf | |
| 12/19/2006 | SUPPL-2 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050795s002lbl.pdf | |
| 05/06/2005 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050795lbl.pdf |