BAUSCH FDA Approval NDA 050649

NDA 050649

BAUSCH

FDA Drug Application

Application #050649

Documents

Letter2002-02-01
Letter2002-02-01
Letter2002-05-31
Letter2004-06-01
Letter2005-10-20
Letter2007-04-09
Letter2007-02-02
Letter2008-07-01
Label2007-04-06
Label2010-09-20
Letter2005-02-17
Letter2004-06-01
Letter2007-06-04
Letter2010-09-17
Letter2015-03-11
Label2007-01-25
Label2008-06-30
Label2015-03-26
Review2004-06-29
Letter2016-12-15
Label2016-12-14
Label2017-07-20
Letter2017-07-21

Application Sponsors

NDA 050649BAUSCH

Marketing Status

Prescription001
Prescription002
Discontinued003

Application Products

001CAPSULE;ORALEQ 50MG BASE1MINOCINMINOCYCLINE HYDROCHLORIDE
002CAPSULE;ORALEQ 100MG BASE1MINOCINMINOCYCLINE HYDROCHLORIDE
003CAPSULE;ORALEQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**1MINOCINMINOCYCLINE HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP1990-05-31STANDARD
LABELING; LabelingSUPPL2AP1992-03-26
LABELING; LabelingSUPPL3AP1992-05-12
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1993-01-28STANDARD
LABELING; LabelingSUPPL5AP2002-02-01STANDARD
LABELING; LabelingSUPPL6AP1995-08-08STANDARD
LABELING; LabelingSUPPL7AP2002-02-01STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL8AP1998-08-05STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL9AP1998-08-05STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL10AP1998-08-05STANDARD
LABELING; LabelingSUPPL11AP2002-05-31STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL12AP2001-03-29STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL13AP2001-02-12STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL14AP2002-01-28STANDARD
LABELING; LabelingSUPPL15AP2005-02-17STANDARD
LABELING; LabelingSUPPL16AP2004-05-27STANDARD
LABELING; LabelingSUPPL17AP2004-05-27STANDARD
LABELING; LabelingSUPPL18AP2005-09-28STANDARD
LABELING; LabelingSUPPL19AP2007-04-02STANDARD
LABELING; LabelingSUPPL20AP2007-01-23STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL21AP2007-05-30N/A
LABELING; LabelingSUPPL22AP2008-06-30STANDARD
LABELING; LabelingSUPPL23AP2010-09-14UNKNOWN
MANUF (CMC); Manufacturing (CMC)SUPPL24AP2014-05-29STANDARD
LABELING; LabelingSUPPL25AP2015-03-09STANDARD
LABELING; LabelingSUPPL26AP2016-12-14STANDARD
LABELING; LabelingSUPPL27AP2017-07-19STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.

Submissions Property Types

SUPPL1Null0
SUPPL4Null0
SUPPL8Null0
SUPPL9Null0
SUPPL10Null0
SUPPL12Null0
SUPPL13Null0
SUPPL14Null0
SUPPL16Null9
SUPPL23Null31
SUPPL24Null0
SUPPL25Null15
SUPPL26Null6
SUPPL27Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

BAUSCH
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50649
            [companyName] => BAUSCH
            [docInserts] => ["",""]
            [products] => [{"drugName":"MINOCIN","activeIngredients":"MINOCYCLINE HYDROCHLORIDE","strength":"EQ 50MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"MINOCIN","activeIngredients":"MINOCYCLINE HYDROCHLORIDE","strength":"EQ 100MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"MINOCIN","activeIngredients":"MINOCYCLINE HYDROCHLORIDE","strength":"EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"07\/19\/2017","submission":"SUPPL-27","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/050649s027lbl.pdf\"}]","notes":"Please see"},{"actionDate":"12\/14\/2016","submission":"SUPPL-26","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/050649s026lbl.pdf\"}]","notes":""},{"actionDate":"03\/09\/2015","submission":"SUPPL-25","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/050649s025lbl.pdf\"}]","notes":""},{"actionDate":"09\/14\/2010","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/050649023lbl.pdf\"}]","notes":""},{"actionDate":"06\/30\/2008","submission":"SUPPL-22","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/050649s022lbl.pdf\"}]","notes":""},{"actionDate":"04\/02\/2007","submission":"SUPPL-19","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/050649s019lbl.pdf\"}]","notes":""},{"actionDate":"01\/23\/2007","submission":"SUPPL-20","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/050649S020_LBL.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"MINOCIN","submission":"MINOCYCLINE HYDROCHLORIDE","actionType":"EQ 50MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"MINOCIN","submission":"MINOCYCLINE HYDROCHLORIDE","actionType":"EQ 100MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"MINOCIN","submission":"MINOCYCLINE HYDROCHLORIDE","actionType":"EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2017-07-19
        )

)
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