ANDA 090109

SAGENT PHARMS INC

FDA Drug Application

Application #090109

Application Sponsors

ANDA 090109

SAGENT PHARMS INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 150MG BASE/ML

0

CLINDAMYCIN PHOSPHATE

CLINDAMYCIN PHOSPHATE

FDA Submissions

	ORIG	1	AP	2011-09-30
LABELING; Labeling	SUPPL	7	AP	2018-04-16	STANDARD
LABELING; Labeling	SUPPL	8	AP	2018-04-16	STANDARD
LABELING; Labeling	SUPPL	11	AP	2018-04-16	STANDARD
LABELING; Labeling	SUPPL	12	AP	2018-04-16	STANDARD
LABELING; Labeling	SUPPL	13	AP	2021-02-09	STANDARD
LABELING; Labeling	SUPPL	15	AP	2021-02-09	STANDARD
LABELING; Labeling	SUPPL	16	AP	2021-02-09	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	7	Null	15
SUPPL	8	Null	7
SUPPL	11	Null	15
SUPPL	12	Null	15
SUPPL	13	Null	15
SUPPL	15	Null	15
SUPPL	16	Null	7

TE Codes

001

Prescription

AP

CDER Filings

SAGENT PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90109
            [companyName] => SAGENT PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLINDAMYCIN PHOSPHATE","activeIngredients":"CLINDAMYCIN PHOSPHATE","strength":"EQ 150MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CLINDAMYCIN PHOSPHATE","submission":"CLINDAMYCIN PHOSPHATE","actionType":"EQ 150MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)