MAYNE PHARMA FDA Approval NDA 050795

NDA 050795

MAYNE PHARMA

FDA Drug Application

Application #050795

Documents

Letter2005-05-17
Letter2011-03-24
Letter2015-06-10
Label2007-12-27
Label2008-06-26
Label2013-04-16
Label2011-03-28
Label2011-09-16
Label2016-04-01
Label2015-03-12
Review2015-11-18
Letter2006-12-28
Letter2008-01-09
Letter2008-06-24
Letter2013-04-16
Letter2016-04-01
Letter2015-03-06
Letter2016-05-20
Letter2016-05-24
Label2005-05-17
Label2006-12-26
Label2015-06-10
Label2016-05-20
Label2016-05-23
Review2006-04-21
Label2017-06-01
Letter2017-06-05
Label2018-02-08
Letter2018-02-08
Pediatric Clinical Pharmacology Review1900-01-01
Pediatric Statistical Review1900-01-01
Pediatric Medical Review1900-01-01
Label2020-02-13
Letter2020-02-13
Review2020-03-19
Letter2022-07-26
Label2022-07-26

Application Sponsors

NDA 050795MAYNE PHARMA

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005
Prescription006
Discontinued007
Prescription008

Application Products

001TABLET, DELAYED RELEASE;ORALEQ 75MG BASE1DORYXDOXYCYCLINE HYCLATE
002TABLET, DELAYED RELEASE;ORALEQ 100MG BASE1DORYXDOXYCYCLINE HYCLATE
003TABLET, DELAYED RELEASE;ORALEQ 150MG BASE1DORYXDOXYCYCLINE HYCLATE
004TABLET, DELAYED RELEASE;ORALEQ 80MG BASE1DORYXDOXYCYCLINE HYCLATE
005TABLET, DELAYED RELEASE;ORALEQ 200MG BASE1DORYXDOXYCYCLINE HYCLATE
006TABLET, DELAYED RELEASE;ORALEQ 50MG BASE1DORYXDOXYCYCLINE HYCLATE
007TABLET, DELAYED RELEASE;ORALEQ 60MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**1DORYX MPCDOXYCYCLINE HYCLATE
008TABLET, DELAYED RELEASE;ORALEQ 120MG BASE1DORYX MPCDOXYCYCLINE HYCLATE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2005-05-06STANDARD
EFFICACY; EfficacySUPPL2AP2006-12-19UNKNOWN
LABELING; LabelingSUPPL3AP2007-12-18STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL5AP2008-06-20N/A
EFFICACY; EfficacySUPPL10AP2013-04-11PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL11AP2013-04-11STANDARD
LABELING; LabelingSUPPL13AP2011-03-21STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL14AP2011-09-13STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL15AP2013-11-25STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL16AP2013-12-06STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL17AP2013-12-06STANDARD
LABELING; LabelingSUPPL18AP2015-06-04STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL19AP2014-12-19STANDARD
LABELING; LabelingSUPPL20AP2015-03-04STANDARD
LABELING; LabelingSUPPL21AP2016-05-18STANDARD
EFFICACY; EfficacySUPPL22AP2016-05-20STANDARD
EFFICACY; EfficacySUPPL24AP2017-05-31STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
LABELING; LabelingSUPPL26AP2018-02-07STANDARD
LABELING; LabelingSUPPL28AP2020-02-12STANDARD
LABELING; LabelingSUPPL30AP2022-07-25STANDARD

Submissions Property Types

SUPPL10Null7
SUPPL11Null0
SUPPL13Null7
SUPPL14Null0
SUPPL15Null0
SUPPL16Null0
SUPPL17Null0
SUPPL18Null15
SUPPL19Null0
SUPPL20Null15
SUPPL21Null6
SUPPL22Null6
SUPPL24Null7
SUPPL26Null6
SUPPL28Null15
SUPPL30Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
005PrescriptionAB
006PrescriptionAB

CDER Filings

MAYNE PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50795
            [companyName] => MAYNE PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"DORYX","activeIngredients":"DOXYCYCLINE HYCLATE","strength":"EQ 75MG BASE","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"DORYX","activeIngredients":"DOXYCYCLINE HYCLATE","strength":"EQ 100MG BASE","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"DORYX","activeIngredients":"DOXYCYCLINE HYCLATE","strength":"EQ 150MG BASE","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"DORYX","activeIngredients":"DOXYCYCLINE HYCLATE","strength":"EQ 80MG BASE","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"DORYX","activeIngredients":"DOXYCYCLINE HYCLATE","strength":"EQ 200MG BASE","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"DORYX","activeIngredients":"DOXYCYCLINE HYCLATE","strength":"EQ 50MG BASE","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"DORYX MPC","activeIngredients":"DOXYCYCLINE HYCLATE","strength":"EQ 60MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"DORYX MPC","activeIngredients":"DOXYCYCLINE HYCLATE","strength":"EQ 120MG BASE","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"02\/12\/2020","submission":"SUPPL-28","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/050795s028lbl.pdf\"}]","notes":""},{"actionDate":"02\/07\/2018","submission":"SUPPL-26","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/050795s026lbl.pdf\"}]","notes":""},{"actionDate":"05\/31\/2017","submission":"SUPPL-24","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/050795s024lbl.pdf\"}]","notes":"Please see"},{"actionDate":"05\/20\/2016","submission":"SUPPL-22","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/050795s022lbl.pdf\"}]","notes":""},{"actionDate":"05\/18\/2016","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/050795s021lbl.pdf\"}]","notes":""},{"actionDate":"05\/18\/2016","submission":"SUPPL-21","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/050795s021lbl.pdf\"}]","notes":""},{"actionDate":"05\/18\/2016","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/050795s021lbl.pdf\"}]","notes":""},{"actionDate":"06\/04\/2015","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/050795s018lbl.pdf\"}]","notes":""},{"actionDate":"03\/04\/2015","submission":"SUPPL-20","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/050795Orig1s020lbl.pdf\"}]","notes":""},{"actionDate":"12\/19\/2014","submission":"SUPPL-19","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/050795Orig1s019lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"04\/11\/2013","submission":"SUPPL-10","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/050795s010lbl.pdf\"}]","notes":""},{"actionDate":"09\/13\/2011","submission":"SUPPL-14","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/050795s014lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"03\/21\/2011","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/050795s013lbl.pdf\"}]","notes":""},{"actionDate":"06\/20\/2008","submission":"SUPPL-5","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/050795s005lbl.pdf\"}]","notes":""},{"actionDate":"06\/20\/2008","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/050795s005lbl.pdf\"}]","notes":""},{"actionDate":"12\/18\/2007","submission":"SUPPL-3","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/050795s003lbl.pdf\"}]","notes":""},{"actionDate":"12\/19\/2006","submission":"SUPPL-2","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/050795s002lbl.pdf\"}]","notes":""},{"actionDate":"05\/06\/2005","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/050795lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"DORYX","submission":"DOXYCYCLINE HYCLATE","actionType":"EQ 75MG BASE","submissionClassification":"TABLET, DELAYED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"DORYX","submission":"DOXYCYCLINE HYCLATE","actionType":"EQ 100MG BASE","submissionClassification":"TABLET, DELAYED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"DORYX","submission":"DOXYCYCLINE HYCLATE","actionType":"EQ 150MG BASE","submissionClassification":"TABLET, DELAYED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"DORYX","submission":"DOXYCYCLINE HYCLATE","actionType":"EQ 80MG BASE","submissionClassification":"TABLET, DELAYED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"DORYX","submission":"DOXYCYCLINE HYCLATE","actionType":"EQ 200MG BASE","submissionClassification":"TABLET, DELAYED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"DORYX","submission":"DOXYCYCLINE HYCLATE","actionType":"EQ 50MG BASE","submissionClassification":"TABLET, DELAYED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"DORYX MPC","submission":"DOXYCYCLINE HYCLATE","actionType":"EQ 60MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET, DELAYED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"DORYX MPC","submission":"DOXYCYCLINE HYCLATE","actionType":"EQ 120MG BASE","submissionClassification":"TABLET, DELAYED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-02-12
        )

)
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