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 | TABLET, DELAYED RELEASE;ORAL | Discontinued | None | Yes | No |
| DORYX | DOXYCYCLINE HYCLATE | EQ 100MG BASE | TABLET, DELAYED RELEASE;ORAL | Discontinued | None | Yes | No |
| DORYX | DOXYCYCLINE HYCLATE | EQ 150MG BASE | TABLET, DELAYED RELEASE;ORAL | Discontinued | None | Yes | No |
| DORYX | DOXYCYCLINE HYCLATE | EQ 80MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | AB | Yes | No |
| DORYX | DOXYCYCLINE HYCLATE | EQ 200MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | AB | Yes | No |
| DORYX | DOXYCYCLINE HYCLATE | EQ 50MG BASE | 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 | TABLET, DELAYED RELEASE;ORAL | Discontinued | None | Yes | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 05/06/2005 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050795lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050795ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/050795s000_DoryxTOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/25/2022 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050795s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/050795Orig1s030ltr.pdf | |
| 02/12/2020 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050795s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/050795Orig1s028ltr.pdf | |
| 02/07/2018 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050795s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050795Orig1s026ltr.pdf | |
| 05/31/2017 | SUPPL-24 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (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 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050795Orig1s024ltr.pdf |
| 05/20/2016 | SUPPL-22 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050795s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050795Orig1s022ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/050795Orig1s022.pdf | |
| 05/18/2016 | SUPPL-21 | Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050795s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050795Orig1s021ltr.pdf | |
| 03/04/2015 | SUPPL-20 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050795Orig1s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050795Orig1s020ltr.pdf | |
| 12/19/2014 | SUPPL-19 | Manufacturing (CMC) |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050795Orig1s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050795Orig1s019ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/050795Orig1s019.pdf | |
| 06/04/2015 | SUPPL-18 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050795s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050795Orig1s018ltr.pdf | |
| 12/06/2013 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/06/2013 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/25/2013 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/13/2011 | SUPPL-14 | Manufacturing (CMC) |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050795s014lbl.pdf | |
| 03/21/2011 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050795s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050582s028,050795s013ltr.pdf | |
| 04/11/2013 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/11/2013 | SUPPL-10 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050795s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050795Orig1s010ltr.pdf | |
| 06/20/2008 | SUPPL-5 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050795s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050795s005ltr.pdf | |
| 12/18/2007 | SUPPL-3 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050795s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050795s003ltr.pdf | |
| 12/19/2006 | SUPPL-2 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050795s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050795s002ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 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-Container/Carton Labels | 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-Package Insert | 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-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050795s005lbl.pdf | |
| 06/20/2008 | SUPPL-5 | Labeling-Package Insert | 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 |
DORYX
TABLET, DELAYED RELEASE;ORAL; EQ 80MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DORYX | DOXYCYCLINE HYCLATE | EQ 80MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | Yes | AB | 050795 | MAYNE PHARMA |
TABLET, DELAYED RELEASE;ORAL; EQ 200MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DORYX | DOXYCYCLINE HYCLATE | EQ 200MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | Yes | AB | 050795 | MAYNE PHARMA |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 200MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 090134 | ACTAVIS ELIZABETH |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 200MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 213075 | ALEMBIC |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 200MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 200856 | HERITAGE PHARMS |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 200MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 207494 | PRINSTON INC |
DORYX MPC
TABLET, DELAYED RELEASE;ORAL; EQ 60MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DORYX MPC | DOXYCYCLINE HYCLATE | EQ 60MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | Yes | AB | 050795 | MAYNE PHARMA |