ANDA 062644

PHARMACIA AND UPJOHN

FDA Drug Application

Application #062644

Documents

• Label: 2012-11-27

Application Sponsors

ANDA 062644

PHARMACIA AND UPJOHN

Marketing Status

• Prescription: 001

Application Products

001

FOR SOLUTION;ORAL

EQ 75MG BASE/5ML

0

CLEOCIN

CLINDAMYCIN PALMITATE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1986-04-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1992-09-29
LABELING; Labeling	SUPPL	9	AP	2014-12-11
LABELING; Labeling	SUPPL	15	AP	2007-11-21
LABELING; Labeling	SUPPL	19	AP	2016-11-07
LABELING; Labeling	SUPPL	21	AP	2014-09-25	STANDARD
LABELING; Labeling	SUPPL	22	AP	2014-09-25	STANDARD
LABELING; Labeling	SUPPL	24	AP	2016-11-07	STANDARD
LABELING; Labeling	SUPPL	25	AP	2016-11-07	STANDARD
LABELING; Labeling	SUPPL	27	AP	2017-08-16	STANDARD
LABELING; Labeling	SUPPL	28	AP	2019-10-22	STANDARD
LABELING; Labeling	SUPPL	29	AP	2019-10-22	STANDARD
LABELING; Labeling	SUPPL	31	AP	2020-04-14	STANDARD

Submissions Property Types

SUPPL	5	Null	0
SUPPL	9	Null	15
SUPPL	19	Null	7
SUPPL	21	Null	15
SUPPL	22	Null	7
SUPPL	24	Null	15
SUPPL	25	Null	7
SUPPL	27	Null	7
SUPPL	28	Null	7
SUPPL	29	Null	7
SUPPL	31	Null	7

TE Codes

001

Prescription

AA

CDER Filings

PFIZER

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 62644
            [companyName] => PFIZER
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLEOCIN","activeIngredients":"CLINDAMYCIN PALMITATE HYDROCHLORIDE","strength":"EQ 75MG BASE\/5ML","dosageForm":"FOR SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => [{"actionDate":"11\/21\/2007","submission":"SUPPL-15","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/062644s015lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"CLEOCIN","submission":"CLINDAMYCIN PALMITATE HYDROCHLORIDE","actionType":"EQ 75MG BASE\/5ML","submissionClassification":"FOR SOLUTION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2007-11-21
        )

)