BAUSCH FDA Approval NDA 050445

NDA 050445

BAUSCH

FDA Drug Application

Application #050445

Documents

Letter2002-02-01
Letter2002-02-01
Letter2002-05-31
Letter2004-06-01
Letter2010-09-16
Label2005-09-30
Label2010-09-20
Letter2002-02-01
Letter2002-02-01
Letter2005-02-17
Letter2004-06-01
Letter2005-10-20
Letter2007-01-18
Letter2015-02-27
Label2007-01-18
Label2015-03-02
Review2004-06-29
Label2018-11-20
Letter2018-11-20

Application Sponsors

NDA 050445BAUSCH

Marketing Status

Discontinued001

Application Products

001SUSPENSION;ORALEQ 50MG BASE/5ML0MINOCINMINOCYCLINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP1972-10-26UNKNOWN
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1985-01-16
LABELING; LabelingSUPPL5AP1986-10-29
LABELING; LabelingSUPPL7AP1987-05-01
LABELING; LabelingSUPPL8AP1987-10-06
LABELING; LabelingSUPPL11AP2002-02-01
MANUF (CMC); Manufacturing (CMC)SUPPL12AP1991-04-10
LABELING; LabelingSUPPL13AP2002-02-01
LABELING; LabelingSUPPL14AP1992-05-12
LABELING; LabelingSUPPL15AP2002-02-01STANDARD
LABELING; LabelingSUPPL16AP1995-08-08STANDARD
LABELING; LabelingSUPPL17AP2002-02-01STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL18AP1998-08-12
LABELING; LabelingSUPPL19AP2002-05-31STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL20AP2001-03-26
MANUF (CMC); Manufacturing (CMC)SUPPL21AP2002-01-28
LABELING; LabelingSUPPL22AP2005-02-17STANDARD
LABELING; LabelingSUPPL23AP2004-05-27STANDARD
LABELING; LabelingSUPPL24AP2004-05-27STANDARD
LABELING; LabelingSUPPL26AP2005-09-28STANDARD
LABELING; LabelingSUPPL27AP2007-01-16STANDARD
LABELING; LabelingSUPPL28AP2010-09-14UNKNOWN
LABELING; LabelingSUPPL29AP2015-02-25STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
LABELING; LabelingSUPPL30AP2018-11-16STANDARD

Submissions Property Types

SUPPL1Null0
SUPPL4Null0
SUPPL12Null0
SUPPL18Null0
SUPPL20Null0
SUPPL21Null0
SUPPL24Null9
SUPPL28Null31
SUPPL29Null6
SUPPL30Null7

CDER Filings

BAUSCH
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50445
            [companyName] => BAUSCH
            [docInserts] => ["",""]
            [products] => [{"drugName":"MINOCIN","activeIngredients":"MINOCYCLINE HYDROCHLORIDE","strength":"EQ 50MG BASE\/5ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"11\/16\/2018","submission":"SUPPL-30","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/050445s030lbl.pdf\"}]","notes":""},{"actionDate":"02\/25\/2015","submission":"SUPPL-29","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/050445s029lbl.pdf\"}]","notes":"Please see"},{"actionDate":"09\/14\/2010","submission":"SUPPL-28","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/050445s028lbl.pdf\"}]","notes":""},{"actionDate":"01\/16\/2007","submission":"SUPPL-27","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/050444s045,050445s027lbl.pdf\"}]","notes":""},{"actionDate":"09\/28\/2005","submission":"SUPPL-26","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/050444s044lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"MINOCIN","submission":"MINOCYCLINE HYDROCHLORIDE","actionType":"EQ 50MG BASE\/5ML","submissionClassification":"SUSPENSION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2018-11-16
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.