ANDA 090108

SAGENT PHARMS INC

FDA Drug Application

Application #090108

Application Sponsors

ANDA 090108

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	5	AP	2018-04-16	STANDARD
LABELING; Labeling	SUPPL	6	AP	2018-04-16	STANDARD
LABELING; Labeling	SUPPL	9	AP	2018-04-16	STANDARD
LABELING; Labeling	SUPPL	10	AP	2018-04-16	STANDARD
LABELING; Labeling	SUPPL	11	AP	2021-02-11	STANDARD
LABELING; Labeling	SUPPL	13	AP	2021-02-11	STANDARD
LABELING; Labeling	SUPPL	15	AP	2021-02-11	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	5	Null	15
SUPPL	6	Null	7
SUPPL	9	Null	15
SUPPL	10	Null	15
SUPPL	11	Null	7
SUPPL	13	Null	15
SUPPL	15	Null	15

TE Codes

001

Prescription

AP

CDER Filings

SAGENT PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90108
            [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
        )

)