NDA 050537

PHARMACIA AND UPJOHN

FDA Drug Application

Application #050537

Documents

• Letter: 2003-06-08
• Letter: 2014-04-07
• Label: 2002-07-14
• Label: 2003-06-08
• Label: 2014-04-08
• Label: 2016-01-26
• Letter: 2002-07-14
• Letter: 2016-01-20
• Label: 2017-11-17
• Letter: 2017-11-17
• Letter: 2019-04-24
• Label: 2019-05-15
• Label: 2019-12-17
• Letter: 2019-12-19

Application Sponsors

NDA 050537

PHARMACIA AND UPJOHN

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	SOLUTION;TOPICAL	EQ 1% BASE	1	CLEOCIN T	CLINDAMYCIN PHOSPHATE
002	SWAB;TOPICAL	EQ 1% BASE	1	CLEOCIN	CLINDAMYCIN PHOSPHATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1980-07-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1980-09-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1980-09-30	STANDARD
LABELING; Labeling	SUPPL	4	AP	1983-03-02
LABELING; Labeling	SUPPL	5	AP	1986-07-18
LABELING; Labeling	SUPPL	6	AP	1984-08-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1986-01-23	STANDARD
LABELING; Labeling	SUPPL	8	AP	1981-05-11
LABELING; Labeling	SUPPL	9	AP	1981-04-20
LABELING; Labeling	SUPPL	10	AP	1989-03-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1989-07-28	STANDARD
LABELING; Labeling	SUPPL	13	AP	2002-07-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1994-02-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1992-12-21	STANDARD
LABELING; Labeling	SUPPL	18	AP	1981-11-18
LABELING; Labeling	SUPPL	19	AP	1981-11-23
LABELING; Labeling	SUPPL	21	AP	1982-02-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1981-08-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1994-09-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1999-06-07	STANDARD
LABELING; Labeling	SUPPL	26	AP	2003-05-30	STANDARD
LABELING; Labeling	SUPPL	35	AP	2014-04-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	36	AP	2014-08-29	STANDARD
LABELING; Labeling	SUPPL	37	AP	2016-01-15	STANDARD
LABELING; Labeling	SUPPL	39	AP	2017-11-16	STANDARD
LABELING; Labeling	SUPPL	40	AP	2019-04-19	STANDARD
LABELING; Labeling	SUPPL	41	AP	2019-12-16	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	7	Null	0
SUPPL	11	Null	0
SUPPL	14	Null	0
SUPPL	16	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0
SUPPL	24	Null	0
SUPPL	35	Null	15
SUPPL	36	Null	0
SUPPL	37	Null	15
SUPPL	39	Null	15
SUPPL	40	Null	6
SUPPL	41	Null	6

TE Codes

001	Prescription	AT
002	Prescription	AT

CDER Filings

PFIZER

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50537
            [companyName] => PFIZER
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLEOCIN","activeIngredients":"CLINDAMYCIN PHOSPHATE","strength":"EQ 1% BASE","dosageForm":"SWAB;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"CLEOCIN T","activeIngredients":"CLINDAMYCIN PHOSPHATE","strength":"EQ 1% BASE","dosageForm":"SOLUTION;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"12\/16\/2019","submission":"SUPPL-41","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/050537s041,050600s018,050615s019lbl.pdf\"}]","notes":""},{"actionDate":"04\/19\/2019","submission":"SUPPL-40","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/050537s040,050600s017,050615s018lbl.pdf\"}]","notes":""},{"actionDate":"11\/16\/2017","submission":"SUPPL-39","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/050537s039,050600s016,050615s016lbl.pdf\"}]","notes":""},{"actionDate":"01\/15\/2016","submission":"SUPPL-37","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/050537s037,050600s014,050615s014lbl.pdf\"}]","notes":""},{"actionDate":"04\/04\/2014","submission":"SUPPL-35","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/050537s035,050600s013,050615s012lbl.pdf\"}]","notes":""},{"actionDate":"05\/30\/2003","submission":"SUPPL-26","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/50537slr026,50600slr007,50615slr005_cleocin_lbl.pdf\"}]","notes":""},{"actionDate":"07\/14\/2002","submission":"SUPPL-13","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/50537s13lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"CLEOCIN","submission":"CLINDAMYCIN PHOSPHATE","actionType":"EQ 1% BASE","submissionClassification":"SWAB;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"CLEOCIN T","submission":"CLINDAMYCIN PHOSPHATE","actionType":"EQ 1% BASE","submissionClassification":"SOLUTION;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-12-16
        )

)