NDA 050767

PHARMACIA AND UPJOHN

FDA Drug Application

Application #050767

Documents

• Letter: 2014-05-12
• Letter: 2015-07-15
• Label: 1999-08-13
• Label: 2013-06-26
• Label: 2014-05-12
• Letter: 1999-08-13
• Letter: 2013-06-20
• Label: 2015-07-16
• Review: 1999-08-13
• Label: 2017-09-11
• Letter: 2017-09-15
• Label: 2018-12-21
• Letter: 2019-09-17
• Label: 2019-09-18
• Label: 2020-03-24
• Letter: 2020-03-24
• Letter: 2022-05-18
• Label: 2022-05-19
• Letter: 2022-07-27
• Label: 2022-08-05

Application Sponsors

NDA 050767

PHARMACIA AND UPJOHN

Marketing Status

• Prescription: 001

Application Products

001

SUPPOSITORY;VAGINAL

100MG

1

CLEOCIN

CLINDAMYCIN PHOSPHATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1999-08-13	STANDARD
LABELING; Labeling	SUPPL	10	AP	2013-06-19	STANDARD
LABELING; Labeling	SUPPL	11	AP	2014-05-09	STANDARD
LABELING; Labeling	SUPPL	12	AP	2015-07-13	STANDARD
LABELING; Labeling	SUPPL	14	AP	2017-09-08	STANDARD
LABELING; Labeling	SUPPL	15	AP	2018-12-20	STANDARD
LABELING; Labeling	SUPPL	16	AP	2019-09-16	STANDARD
LABELING; Labeling	SUPPL	17	AP	2020-03-23	STANDARD
LABELING; Labeling	SUPPL	18	AP	2022-05-17	STANDARD
LABELING; Labeling	SUPPL	19	AP	2022-07-26	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	10	Null	7
SUPPL	11	Null	7
SUPPL	12	Null	15
SUPPL	14	Null	7
SUPPL	15	Null	15
SUPPL	16	Null	6
SUPPL	17	Null	6
SUPPL	18	Null	6
SUPPL	19	Null	15

CDER Filings

PFIZER

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50767
            [companyName] => PFIZER
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLEOCIN","activeIngredients":"CLINDAMYCIN PHOSPHATE","strength":"100MG","dosageForm":"SUPPOSITORY;VAGINAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"03\/23\/2020","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/050680s018,050767s017lbl.pdf\"}]","notes":""},{"actionDate":"09\/16\/2019","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/050767s016lbl.pdf\"}]","notes":""},{"actionDate":"12\/20\/2018","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/050680s016,050767s015lbl.pdf\"}]","notes":""},{"actionDate":"09\/08\/2017","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/050680s013,050767s014lbl.pdf\"}]","notes":""},{"actionDate":"07\/13\/2015","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/050680s011,050767s012lbl.pdf\"}]","notes":""},{"actionDate":"05\/09\/2014","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/050680s010,050767s011lbl.pdf\"}]","notes":""},{"actionDate":"05\/09\/2014","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/050680s010,050767s011lbl.pdf\"}]","notes":""},{"actionDate":"06\/19\/2013","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/050767s010lbl.pdf\"}]","notes":""},{"actionDate":"08\/13\/1999","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1999\\\/50767lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"CLEOCIN","submission":"CLINDAMYCIN PHOSPHATE","actionType":"100MG","submissionClassification":"SUPPOSITORY;VAGINAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-03-23
        )

)