BAUSCH FDA Approval NDA 050756

NDA 050756

BAUSCH

FDA Drug Application

Application #050756

Documents

Letter2000-12-21
Letter2002-08-09
Letter2009-06-17
Letter2010-06-18
Letter2011-03-08
Label2000-12-21
Label2005-05-02
Label2007-05-29
Label2007-04-25
Label2011-03-07
Letter2005-05-02
Letter2007-06-04
Letter2007-05-01
Label2002-08-09
Label2009-06-22
Label2010-06-24
Review2000-12-21

Application Sponsors

NDA 050756BAUSCH

Marketing Status

Prescription001
Discontinued002

Application Products

001GEL;TOPICAL5%;EQ 1% BASE1BENZACLINBENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
002GEL;TOPICAL5%;EQ 1% BASE0BENZACLINBENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE

FDA Submissions

TYPE 4; Type 4 - New CombinationORIG1AP2000-12-21STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL2AP2001-08-30STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL3AP2001-10-12STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL4AP2001-09-25STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL5AP2001-09-26STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL6AP2002-03-26STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL7AP2002-08-09STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL8AP2002-06-27STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL9AP2002-08-28STANDARD
LABELING; LabelingSUPPL16AP2005-04-28STANDARD
LABELING; LabelingSUPPL26AP2007-05-23STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL27AP2007-04-20N/A
LABELING; LabelingSUPPL34AP2009-06-12STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL35AP2010-06-14N/A
LABELING; LabelingSUPPL37AP2010-06-17UNKNOWN
MANUF (CMC); Manufacturing (CMC)SUPPL40AP2011-03-02STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL43AP2014-09-22STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL44AP2014-12-05STANDARD

Submissions Property Types

SUPPL1Null0
SUPPL2Null0
SUPPL3Null0
SUPPL4Null0
SUPPL5Null0
SUPPL6Null0
SUPPL7Null0
SUPPL8Null0
SUPPL9Null0
SUPPL35Null6
SUPPL37Null7
SUPPL40Null0
SUPPL43Null0
SUPPL44Null0

TE Codes

001PrescriptionAB

CDER Filings

BAUSCH
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50756
            [companyName] => BAUSCH
            [docInserts] => ["",""]
            [products] => [{"drugName":"BENZACLIN","activeIngredients":"BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE","strength":"5%;EQ 1% BASE","dosageForm":"GEL;TOPICAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"BENZACLIN","activeIngredients":"BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE","strength":"5%;EQ 1% BASE","dosageForm":"GEL;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"03\/02\/2011","submission":"SUPPL-40","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/050756s040lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"06\/17\/2010","submission":"SUPPL-37","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/050756s037lbl.pdf\"}]","notes":""},{"actionDate":"06\/12\/2009","submission":"SUPPL-34","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/050756s034lbl.pdf\"}]","notes":""},{"actionDate":"05\/23\/2007","submission":"SUPPL-26","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/050756s026lbl.pdf\"}]","notes":""},{"actionDate":"04\/20\/2007","submission":"SUPPL-27","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/050756s027lbl.pdf\"}]","notes":""},{"actionDate":"04\/28\/2005","submission":"SUPPL-16","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/050756s016lbl.pdf\"}]","notes":""},{"actionDate":"08\/09\/2002","submission":"SUPPL-7","supplementCategories":"Manufacturing (CMC)-Packaging","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/50756s7lbl.pdf\"}]","notes":""},{"actionDate":"12\/21\/2000","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2000\\\/50-756_Benzaclin_prntlbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"BENZACLIN","submission":"BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE","actionType":"5%;EQ 1% BASE","submissionClassification":"GEL;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"BENZACLIN","submission":"BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE","actionType":"5%;EQ 1% BASE","submissionClassification":"GEL;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2011-03-02
        )

)

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