PHARMACIA AND UPJOHN FDA Approval NDA 050639

Application #050639

Documents

Letter	2004-10-04
Letter	2008-04-16
Letter	2011-06-10
Letter	2014-06-27
Letter	2014-06-27
Label	2008-02-25
Label	2008-04-23
Label	2014-07-03
Label	2014-07-03
Letter	2004-02-02
Letter	2008-02-25
Letter	2014-06-27
Letter	2016-03-28
Label	2004-10-04
Label	2014-07-03
Label	2016-03-29
Letter	2016-08-05
Letter	2016-08-05
Label	2016-08-05
Label	2016-08-05
Label	2017-05-05
Label	2017-05-05
Letter	2017-05-08
Letter	2017-05-08
Label	2018-04-17
Letter	2018-04-17
Label	2019-06-20
Letter	2019-06-20
Letter	2020-03-05
Label	2020-03-05
Label	2021-12-07
Letter	2021-12-07
Letter	2022-05-23
Label	2022-05-23

Application Sponsors

NDA 050639

PHARMACIA AND UPJOHN

Marketing Status

Prescription	001
Prescription	002
Prescription	003

Application Products

001	INJECTABLE;INJECTION	EQ 6MG BASE/ML	1	CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER	CLINDAMYCIN PHOSPHATE
002	INJECTABLE;INJECTION	EQ 12MG BASE/ML	1	CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER	CLINDAMYCIN PHOSPHATE
003	INJECTABLE;INJECTION	EQ 18MG BASE/ML	1	CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER	CLINDAMYCIN PHOSPHATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1989-08-30	STANDARD
LABELING; Labeling	SUPPL	2	AP	1991-06-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1991-04-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1992-05-21	STANDARD
LABELING; Labeling	SUPPL	5	AP	1997-03-17
LABELING; Labeling	SUPPL	7	AP	1995-12-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1993-04-05	STANDARD
LABELING; Labeling	SUPPL	9	AP	1995-02-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1998-03-09	STANDARD
LABELING; Labeling	SUPPL	11	AP	1997-07-17	STANDARD
LABELING; Labeling	SUPPL	12	AP	1997-12-12	STANDARD
LABELING; Labeling	SUPPL	13	AP	2004-09-29	STANDARD
LABELING; Labeling	SUPPL	14	AP	2004-01-28	STANDARD
LABELING; Labeling	SUPPL	15	AP	2008-02-21	STANDARD
LABELING; Labeling	SUPPL	16	AP	2008-04-14	STANDARD
LABELING; Labeling	SUPPL	22	AP	2011-06-07	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	2013-06-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	2013-10-09	STANDARD
LABELING; Labeling	SUPPL	27	AP	2014-06-25	STANDARD
LABELING; Labeling	SUPPL	28	AP	2014-06-25	STANDARD
LABELING; Labeling	SUPPL	29	AP	2014-06-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	2014-09-18	STANDARD
LABELING; Labeling	SUPPL	31	AP	2016-03-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	2016-05-20	STANDARD
LABELING; Labeling	SUPPL	33	AP	2016-08-05	STANDARD
LABELING; Labeling	SUPPL	34	AP	2016-08-05	STANDARD
LABELING; Labeling	SUPPL	35	AP	2017-05-02	STANDARD
LABELING; Labeling	SUPPL	37	AP	2017-05-02	STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
LABELING; Labeling	SUPPL	38	AP	2018-04-16	STANDARD
LABELING; Labeling	SUPPL	40	AP	2019-06-19	STANDARD
LABELING; Labeling	SUPPL	41	AP	2020-03-04	STANDARD
LABELING; Labeling	SUPPL	42	AP	2022-05-20	STANDARD
LABELING; Labeling	SUPPL	43	AP	2021-12-04	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	8	Null	0
SUPPL	10	Null	0
SUPPL	22	Null	7
SUPPL	25	Null	0
SUPPL	26	Null	0
SUPPL	27	Null	6
SUPPL	28	Null	6
SUPPL	29	Null	6
SUPPL	30	Null	0
SUPPL	31	Null	6
SUPPL	32	Null	0
SUPPL	33	Null	15
SUPPL	34	Null	6
SUPPL	35	Null	7
SUPPL	37	Null	6
SUPPL	38	Null	7
SUPPL	40	Null	7
SUPPL	41	Null	7
SUPPL	42	Null	15
SUPPL	43	Null	7

TE Codes

001	Prescription	AP
002	Prescription	AP
003	Prescription	AP

CDER Filings

PFIZER

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50639
            [companyName] => PFIZER
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"CLINDAMYCIN PHOSPHATE","strength":"EQ 6MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"CLINDAMYCIN PHOSPHATE","strength":"EQ 12MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"CLINDAMYCIN PHOSPHATE","strength":"EQ 18MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"12\/04\/2021","submission":"SUPPL-43","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-41","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-40","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-38","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-37","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-35","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-34","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/050441s073,050639s034lbl.pdf\"}]","notes":""},{"actionDate":"08\/05\/2016","submission":"SUPPL-33","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-31","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/050441s071lbl.pdf\"}]","notes":""},{"actionDate":"06\/25\/2014","submission":"SUPPL-29","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/050639s027s028s029lbl.pdf\"}]","notes":""},{"actionDate":"06\/25\/2014","submission":"SUPPL-28","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/050639s027s028s029lbl.pdf\"}]","notes":""},{"actionDate":"06\/25\/2014","submission":"SUPPL-27","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/050639s027s028s029lbl.pdf\"}]","notes":""},{"actionDate":"04\/14\/2008","submission":"SUPPL-16","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-15","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-13","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/50162s082,50441s045,50639s013lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER","submission":"CLINDAMYCIN PHOSPHATE","actionType":"EQ 6MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER","submission":"CLINDAMYCIN PHOSPHATE","actionType":"EQ 12MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER","submission":"CLINDAMYCIN PHOSPHATE","actionType":"EQ 18MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2021-12-04
        )

)

NDA 050639

PHARMACIA AND UPJOHN

FDA Drug Application

Application #050639

Documents

Application Sponsors

Marketing Status

Application Products

FDA Submissions

Submissions Property Types

TE Codes

CDER Filings

PFIZER