NDA 050162

PHARMACIA AND UPJOHN

FDA Drug Application

Application #050162

Documents

• Letter: 2004-02-02
• Letter: 2010-01-21
• Letter: 2011-06-10
• Letter: 2014-06-27
• Letter: 2016-03-25
• Label: 2004-10-04
• Label: 2009-11-23
• Label: 2016-03-29
• Label: 2016-03-29
• Letter: 2004-10-04
• Letter: 2014-06-27
• Letter: 2016-03-25
• Label: 2014-06-30
• Label: 2014-06-30
• Label: 2017-05-04
• Label: 2017-05-04
• Letter: 2017-05-08
• Letter: 2017-05-08
• Label: 2018-03-16
• Letter: 2018-03-20
• Label: 2019-06-14
• Letter: 2019-06-17
• Letter: 2020-03-10
• Label: 2020-03-10
• Letter: 2022-05-23
• Label: 2022-05-27

Application Sponsors

NDA 050162

PHARMACIA AND UPJOHN

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	CAPSULE;ORAL	EQ 75MG BASE	1	CLEOCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE
002	CAPSULE;ORAL	EQ 150MG BASE	1	CLEOCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE
003	CAPSULE;ORAL	EQ 300MG BASE	1	CLEOCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	1970-02-22	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1970-07-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1983-04-29
LABELING; Labeling	SUPPL	5	AP	1985-09-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1970-09-21
LABELING; Labeling	SUPPL	7	AP	1985-06-21
LABELING; Labeling	SUPPL	9	AP	1997-03-17
LABELING; Labeling	SUPPL	10	AP	1986-10-20
EFFICACY; Efficacy	SUPPL	11	AP	1988-04-14
LABELING; Labeling	SUPPL	12	AP	1971-04-26
LABELING; Labeling	SUPPL	13	AP	1970-11-16
LABELING; Labeling	SUPPL	14	AP	1970-12-09
LABELING; Labeling	SUPPL	15	AP	1970-12-15
LABELING; Labeling	SUPPL	16	AP	1970-12-18
LABELING; Labeling	SUPPL	17	AP	1971-05-18
LABELING; Labeling	SUPPL	18	AP	1997-03-17
LABELING; Labeling	SUPPL	19	AP	1971-02-19
LABELING; Labeling	SUPPL	20	AP	1995-02-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1993-03-05
LABELING; Labeling	SUPPL	22	AP	1997-03-17
LABELING; Labeling	SUPPL	24	AP	1971-07-22
LABELING; Labeling	SUPPL	27	AP	1972-02-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1971-06-14
LABELING; Labeling	SUPPL	29	AP	1971-09-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	1972-05-22
LABELING; Labeling	SUPPL	33	AP	1972-02-15
LABELING; Labeling	SUPPL	34	AP	1972-04-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	36	AP	1972-05-11
LABELING; Labeling	SUPPL	37	AP	1972-08-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	38	AP	1972-07-14
LABELING; Labeling	SUPPL	40	AP	1972-07-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	41	AP	1973-01-12
LABELING; Labeling	SUPPL	42	AP	1973-07-19
LABELING; Labeling	SUPPL	43	AP	1973-04-03
LABELING; Labeling	SUPPL	44	AP	1974-04-24
LABELING; Labeling	SUPPL	45	AP	1974-04-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	46	AP	1973-07-20
LABELING; Labeling	SUPPL	47	AP	1973-10-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	48	AP	1973-11-06
LABELING; Labeling	SUPPL	50	AP	1974-08-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	51	AP	1974-06-06
LABELING; Labeling	SUPPL	52	AP	1974-08-09
LABELING; Labeling	SUPPL	53	AP	1975-03-14
LABELING; Labeling	SUPPL	54	AP	1975-03-17
LABELING; Labeling	SUPPL	55	AP	1975-06-11
LABELING; Labeling	SUPPL	56	AP	1975-11-17
LABELING; Labeling	SUPPL	57	AP	1977-08-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	58	AP	1976-01-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	59	AP	1976-06-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	60	AP	1976-07-02
LABELING; Labeling	SUPPL	61	AP	1977-01-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	62	AP	1978-02-14
LABELING; Labeling	SUPPL	63	AP	1978-07-11
LABELING; Labeling	SUPPL	64	AP	1979-06-28
LABELING; Labeling	SUPPL	66	AP	1978-10-04
LABELING; Labeling	SUPPL	67	AP	1979-04-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	68	AP	1979-05-18
LABELING; Labeling	SUPPL	69	AP	1979-07-09
LABELING; Labeling	SUPPL	70	AP	1979-07-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	71	AP	1979-07-20
LABELING; Labeling	SUPPL	72	AP	1979-11-06
LABELING; Labeling	SUPPL	73	AP	1980-04-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	74	AP	1980-05-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	75	AP	1981-05-20
EFFICACY; Efficacy	SUPPL	76	AP	1981-11-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	77	AP	1982-04-27
LABELING; Labeling	SUPPL	79	AP	1997-07-17	STANDARD
LABELING; Labeling	SUPPL	80	AP	1997-12-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	81	AP	1998-02-24
LABELING; Labeling	SUPPL	82	AP	2004-09-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	83	AP	1999-11-15
LABELING; Labeling	SUPPL	84	AP	2004-01-28	STANDARD
LABELING; Labeling	SUPPL	85	AP	2009-11-20	STANDARD
LABELING; Labeling	SUPPL	90	AP	2011-06-07	UNKNOWN
LABELING; Labeling	SUPPL	92	AP	2014-06-26	STANDARD
LABELING; Labeling	SUPPL	93	AP	2014-06-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	94	AP	2016-01-21
LABELING; Labeling	SUPPL	95	AP	2016-03-23	STANDARD
LABELING; Labeling	SUPPL	96	AP	2016-03-23	STANDARD
LABELING; Labeling	SUPPL	97	AP	2016-08-02	STANDARD
LABELING; Labeling	SUPPL	98	AP	2017-05-02	STANDARD
LABELING; Labeling	SUPPL	99	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	100	AP	2018-03-15	STANDARD
LABELING; Labeling	SUPPL	101	AP	2019-06-13	STANDARD
LABELING; Labeling	SUPPL	102	AP	2020-03-09	STANDARD
LABELING; Labeling	SUPPL	104	AP	2022-05-20	STANDARD

Submissions Property Types

SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	21	Null	0
SUPPL	28	Null	0
SUPPL	32	Null	0
SUPPL	36	Null	0
SUPPL	38	Null	0
SUPPL	41	Null	0
SUPPL	46	Null	0
SUPPL	48	Null	0
SUPPL	51	Null	0
SUPPL	58	Null	0
SUPPL	59	Null	0
SUPPL	60	Null	0
SUPPL	62	Null	0
SUPPL	68	Null	0
SUPPL	71	Null	0
SUPPL	74	Null	0
SUPPL	75	Null	0
SUPPL	77	Null	0
SUPPL	81	Null	0
SUPPL	83	Null	0
SUPPL	85	Null	6
SUPPL	90	Null	6
SUPPL	92	Null	7
SUPPL	93	Null	15
SUPPL	94	Null	0
SUPPL	95	Null	6
SUPPL	96	Null	6
SUPPL	97	Null	7
SUPPL	98	Null	15
SUPPL	99	Null	6
SUPPL	100	Null	6
SUPPL	101	Null	6
SUPPL	102	Null	7
SUPPL	104	Null	6

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

PFIZER

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50162
            [companyName] => PFIZER
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLEOCIN HYDROCHLORIDE","activeIngredients":"CLINDAMYCIN HYDROCHLORIDE","strength":"EQ 75MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"CLEOCIN HYDROCHLORIDE","activeIngredients":"CLINDAMYCIN HYDROCHLORIDE","strength":"EQ 150MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"CLEOCIN HYDROCHLORIDE","activeIngredients":"CLINDAMYCIN HYDROCHLORIDE","strength":"EQ 300MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"03\/09\/2020","submission":"SUPPL-102","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/050162s102lbl.pdf\"}]","notes":""},{"actionDate":"06\/13\/2019","submission":"SUPPL-101","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/050162s101lbl.pdf\"}]","notes":""},{"actionDate":"03\/15\/2018","submission":"SUPPL-100","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/050162s100lbl.pdf\"}]","notes":""},{"actionDate":"05\/02\/2017","submission":"SUPPL-99","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/050162s098s099lbl.pdf\"}]","notes":"Please see"},{"actionDate":"05\/02\/2017","submission":"SUPPL-98","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/050162s098s099lbl.pdf\"}]","notes":""},{"actionDate":"03\/23\/2016","submission":"SUPPL-96","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/050162s095s096lbl.pdf\"}]","notes":""},{"actionDate":"03\/23\/2016","submission":"SUPPL-95","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/050162s095s096lbl.pdf\"}]","notes":""},{"actionDate":"06\/26\/2014","submission":"SUPPL-93","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/050162s092s093lbl.pdf\"}]","notes":""},{"actionDate":"06\/26\/2014","submission":"SUPPL-92","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/050162s092s093lbl.pdf\"}]","notes":""},{"actionDate":"11\/20\/2009","submission":"SUPPL-85","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/050162s085lbl.pdf\"}]","notes":""},{"actionDate":"09\/29\/2004","submission":"SUPPL-82","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/50162s082,50441s045,50639s013lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"CLEOCIN HYDROCHLORIDE","submission":"CLINDAMYCIN HYDROCHLORIDE","actionType":"EQ 75MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"CLEOCIN HYDROCHLORIDE","submission":"CLINDAMYCIN HYDROCHLORIDE","actionType":"EQ 150MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"CLEOCIN HYDROCHLORIDE","submission":"CLINDAMYCIN HYDROCHLORIDE","actionType":"EQ 300MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-03-09
        )

)