Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050795
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 Prescription AB Yes No
DORYX DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET, DELAYED RELEASE;ORAL Prescription AB Yes No
DORYX DOXYCYCLINE HYCLATE EQ 150MG BASE TABLET, DELAYED RELEASE;ORAL Prescription AB 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 Prescription AB Yes Yes
DORYX DOXYCYCLINE HYCLATE EQ 50MG BASE TABLET, DELAYED RELEASE;ORAL Prescription AB Yes No
DORYX MPC DOXYCYCLINE HYCLATE EQ 60MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, DELAYED RELEASE;ORAL Discontinued None Yes No
DORYX MPC DOXYCYCLINE HYCLATE EQ 120MG BASE TABLET, DELAYED RELEASE;ORAL 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
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
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)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050795s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050795Orig1s022ltr.pdf
05/18/2016 SUPPL-21 Labeling-Package Insert, Labeling-Container/Carton Labels, 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
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-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
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 75MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DORYX DOXYCYCLINE HYCLATE EQ 75MG BASE TABLET, DELAYED RELEASE;ORAL Prescription Yes AB 050795 MAYNE PHARMA
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 75MG BASE TABLET, DELAYED RELEASE;ORAL Prescription No AB 090134 ACTAVIS ELIZABETH
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 75MG BASE TABLET, DELAYED RELEASE;ORAL Prescription No AB 200856 HERITAGE PHARMS INC

TABLET, DELAYED RELEASE;ORAL; EQ 100MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DORYX DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET, DELAYED RELEASE;ORAL Prescription Yes AB 050795 MAYNE PHARMA
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET, DELAYED RELEASE;ORAL Prescription No AB 090134 ACTAVIS ELIZABETH
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET, DELAYED RELEASE;ORAL Prescription No AB 200856 HERITAGE PHARMS INC

TABLET, DELAYED RELEASE;ORAL; EQ 150MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DORYX DOXYCYCLINE HYCLATE EQ 150MG BASE TABLET, DELAYED RELEASE;ORAL Prescription Yes AB 050795 MAYNE PHARMA
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 150MG BASE TABLET, DELAYED RELEASE;ORAL Prescription No AB 200856 HERITAGE PHARMS INC
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 150MG BASE TABLET, DELAYED RELEASE;ORAL Prescription No AB 207494 PRINSTON INC

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 200856 HERITAGE PHARMS INC
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 200MG BASE TABLET, DELAYED RELEASE;ORAL Prescription No AB 207494 PRINSTON INC

TABLET, DELAYED RELEASE;ORAL; EQ 50MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DORYX DOXYCYCLINE HYCLATE EQ 50MG BASE TABLET, DELAYED RELEASE;ORAL Prescription Yes AB 050795 MAYNE PHARMA
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 50MG BASE TABLET, DELAYED RELEASE;ORAL Prescription No AB 090134 ACTAVIS ELIZABETH
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 50MG BASE TABLET, DELAYED RELEASE;ORAL Prescription No AB 090431 MYLAN

DORYX MPC

There are no Therapeutic Equivalents.

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