PHARMACIA AND UPJOHN FDA Approval NDA 050441

NDA 050441

PHARMACIA AND UPJOHN

FDA Drug Application

Application #050441

Documents

Letter2008-02-25
Letter2008-04-16
Letter2014-06-12
Letter2016-03-28
Label2008-02-25
Label2014-06-25
Label2014-06-25
Label2016-03-29
Letter2004-10-04
Letter2001-11-21
Letter2004-02-02
Letter2010-10-20
Letter2011-06-10
Letter2014-06-12
Letter2014-06-12
Label2004-10-04
Label2003-05-02
Label2008-04-23
Label2014-06-25
Letter2016-08-05
Letter2016-08-05
Label2016-08-05
Label2016-08-05
Label2017-05-04
Label2017-05-04
Letter2017-05-08
Letter2017-05-08
Label2018-04-17
Letter2018-04-17
Label2019-06-20
Letter2019-06-20
Letter2020-03-05
Label2020-03-05
Label2021-12-07
Letter2021-12-07
Letter2022-05-23
Label2022-05-23

Application Sponsors

NDA 050441PHARMACIA AND UPJOHN

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTIONEQ 150MG BASE/ML1CLEOCIN PHOSPHATECLINDAMYCIN PHOSPHATE

FDA Submissions

UNKNOWN; ORIG1AP1972-10-02UNKNOWN
LABELING; LabelingSUPPL23AP1997-03-17
LABELING; LabelingSUPPL25AP1997-03-17
LABELING; LabelingSUPPL35AP1991-06-11
MANUF (CMC); Manufacturing (CMC)SUPPL37AP1993-03-23
LABELING; LabelingSUPPL38AP1997-03-17
LABELING; LabelingSUPPL40AP1996-03-05
LABELING; LabelingSUPPL41AP1995-12-20STANDARD
LABELING; LabelingSUPPL42AP1995-02-21
LABELING; LabelingSUPPL43AP1997-07-17STANDARD
LABELING; LabelingSUPPL44AP1997-12-12STANDARD
LABELING; LabelingSUPPL45AP2004-09-29STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL46AP2000-04-03
LABELING; LabelingSUPPL47AP2001-11-21STANDARD
LABELING; LabelingSUPPL48AP2004-01-28STANDARD
LABELING; LabelingSUPPL53AP2008-02-21STANDARD
LABELING; LabelingSUPPL55AP2008-04-14STANDARD
LABELING; LabelingSUPPL59AP2010-10-15UNKNOWN
LABELING; LabelingSUPPL61AP2011-06-07UNKNOWN
MANUF (CMC); Manufacturing (CMC)SUPPL64AP2012-12-18
LABELING; LabelingSUPPL66AP2014-06-10STANDARD
LABELING; LabelingSUPPL67AP2014-06-10STANDARD
LABELING; LabelingSUPPL68AP2014-06-10STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL70AP2014-10-20
LABELING; LabelingSUPPL71AP2016-03-24STANDARD
LABELING; LabelingSUPPL72AP2016-08-05STANDARD
LABELING; LabelingSUPPL73AP2016-08-05STANDARD
LABELING; LabelingSUPPL76AP2017-05-02STANDARD
LABELING; LabelingSUPPL78AP2017-05-02STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
LABELING; LabelingSUPPL79AP2018-04-16STANDARD
LABELING; LabelingSUPPL81AP2019-06-19STANDARD
LABELING; LabelingSUPPL83AP2020-03-04STANDARD
LABELING; LabelingSUPPL85AP2022-05-20STANDARD
LABELING; LabelingSUPPL86AP2021-12-04STANDARD

Submissions Property Types

SUPPL37Null0
SUPPL46Null0
SUPPL48Null9
SUPPL59Null6
SUPPL61Null7
SUPPL64Null0
SUPPL66Null7
SUPPL67Null15
SUPPL68Null6
SUPPL70Null0
SUPPL71Null15
SUPPL72Null6
SUPPL73Null7
SUPPL76Null15
SUPPL78Null6
SUPPL79Null6
SUPPL81Null15
SUPPL83Null15
SUPPL85Null15
SUPPL86Null7

TE Codes

001PrescriptionAP

CDER Filings

PFIZER
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50441
            [companyName] => PFIZER
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLEOCIN PHOSPHATE","activeIngredients":"CLINDAMYCIN PHOSPHATE","strength":"EQ 150MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"12\/04\/2021","submission":"SUPPL-86","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/050441s086,050639s043lbl.pdf\"}]","notes":""},{"actionDate":"03\/04\/2020","submission":"SUPPL-83","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/050441s083,050639s041lbl.pdf\"}]","notes":""},{"actionDate":"06\/19\/2019","submission":"SUPPL-81","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/050441s081,050639s040lbl.pdf\"}]","notes":""},{"actionDate":"04\/16\/2018","submission":"SUPPL-79","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/050441s079,050639s038lbl.pdf\"}]","notes":""},{"actionDate":"05\/02\/2017","submission":"SUPPL-78","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/050441s076s078,050639s035s037lbl.pdf\"}]","notes":"Please see"},{"actionDate":"05\/02\/2017","submission":"SUPPL-76","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/050441s076s078,050639s035s037lbl.pdf\"}]","notes":""},{"actionDate":"08\/05\/2016","submission":"SUPPL-73","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/2016\\\/050441s073,050639s034lbl.pdf\"}]","notes":""},{"actionDate":"08\/05\/2016","submission":"SUPPL-72","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/050441s072,050639s033lbl.pdf\"}]","notes":""},{"actionDate":"03\/24\/2016","submission":"SUPPL-71","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/050441s071lbl.pdf\"}]","notes":""},{"actionDate":"06\/10\/2014","submission":"SUPPL-68","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"06\/10\/2014","submission":"SUPPL-67","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"06\/10\/2014","submission":"SUPPL-66","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"04\/14\/2008","submission":"SUPPL-55","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/050441s055,050639s016lbl.pdf\"}]","notes":""},{"actionDate":"02\/21\/2008","submission":"SUPPL-53","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/050441s053,050639s015lbl.pdf\"}]","notes":""},{"actionDate":"09\/29\/2004","submission":"SUPPL-45","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/50162s082,50441s045,50639s013lbl.pdf\"}]","notes":""},{"actionDate":"11\/21\/2001","submission":"SUPPL-47","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/50441s47lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"CLEOCIN PHOSPHATE","submission":"CLINDAMYCIN PHOSPHATE","actionType":"EQ 150MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2021-12-04
        )

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