ANDA 062803

PHARMACIA AND UPJOHN

FDA Drug Application

Application #062803

Application Sponsors

ANDA 062803

PHARMACIA AND UPJOHN

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 150MG BASE/ML

0

CLEOCIN PHOSPHATE

CLINDAMYCIN PHOSPHATE

FDA Submissions

	ORIG	1	AP	1987-10-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1990-03-22
LABELING; Labeling	SUPPL	4	AP	1996-04-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1992-07-06
LABELING; Labeling	SUPPL	6	AP	1998-01-12
LABELING; Labeling	SUPPL	8	AP	1993-09-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1992-10-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1996-02-02
LABELING; Labeling	SUPPL	11	AP	1998-10-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2000-04-05
LABELING; Labeling	SUPPL	25	AP	2016-08-18	STANDARD
LABELING; Labeling	SUPPL	26	AP	2016-08-18	STANDARD
LABELING; Labeling	SUPPL	27	AP	2016-08-18	STANDARD
LABELING; Labeling	SUPPL	31	AP	2016-08-18	STANDARD
LABELING; Labeling	SUPPL	32	AP	2016-08-18	STANDARD
LABELING; Labeling	SUPPL	35	AP	2017-09-11	STANDARD

Submissions Property Types

SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	8	Null	1
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	12	Null	0
SUPPL	25	Null	7
SUPPL	26	Null	7
SUPPL	27	Null	7
SUPPL	31	Null	15
SUPPL	32	Null	15
SUPPL	35	Null	7

TE Codes

001

Prescription

AP

CDER Filings

PFIZER

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 62803
            [companyName] => PFIZER
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLEOCIN PHOSPHATE","activeIngredients":"CLINDAMYCIN PHOSPHATE","strength":"EQ 150MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CLEOCIN PHOSPHATE","submission":"CLINDAMYCIN PHOSPHATE","actionType":"EQ 150MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)