NDA 050615

PHARMACIA AND UPJOHN

FDA Drug Application

Application #050615

Documents

• Letter: 2002-07-14
• Letter: 2016-01-20
• Label: 2003-06-08
• Label: 2014-04-08
• Letter: 2003-06-08
• Letter: 2014-04-07
• Label: 2002-07-14
• Label: 2016-01-26
• 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 050615

PHARMACIA AND UPJOHN

Marketing Status

• Prescription: 001

Application Products

001

GEL;TOPICAL

EQ 1% BASE

1

CLEOCIN T

CLINDAMYCIN PHOSPHATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1987-01-07	STANDARD
LABELING; Labeling	SUPPL	3	AP	2002-07-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1998-01-27	STANDARD
LABELING; Labeling	SUPPL	5	AP	2003-05-30	STANDARD
LABELING; Labeling	SUPPL	12	AP	2014-04-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2015-01-12	STANDARD
LABELING; Labeling	SUPPL	14	AP	2016-01-15	STANDARD
LABELING; Labeling	SUPPL	16	AP	2017-11-16	STANDARD
LABELING; Labeling	SUPPL	18	AP	2019-04-19	STANDARD
LABELING; Labeling	SUPPL	19	AP	2019-12-16	STANDARD

Submissions Property Types

SUPPL	4	Null	0
SUPPL	12	Null	15
SUPPL	13	Null	0
SUPPL	14	Null	15
SUPPL	16	Null	4
SUPPL	18	Null	7
SUPPL	19	Null	15

TE Codes

001

Prescription

AB

CDER Filings

PFIZER

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(
    [0] => Array
        (
            [ApplNo] => 50615
            [companyName] => PFIZER
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLEOCIN T","activeIngredients":"CLINDAMYCIN PHOSPHATE","strength":"EQ 1% BASE","dosageForm":"GEL;TOPICAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"12\/16\/2019","submission":"SUPPL-19","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-18","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-16","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-14","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-12","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-5","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-3","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/50537s13lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"CLEOCIN T","submission":"CLINDAMYCIN PHOSPHATE","actionType":"EQ 1% BASE","submissionClassification":"GEL;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-12-16
        )

)