ANDA 090923

SUN PHARM INDS LTD

FDA Drug Application

Application #090923

Application Sponsors

ANDA 090923

SUN PHARM INDS LTD

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 500MG BASE/VIAL

0

AZITHROMYCIN

AZITHROMYCIN

FDA Submissions

	ORIG	1	AP	2013-04-02
LABELING; Labeling	SUPPL	2	AP	2015-03-19	STANDARD
LABELING; Labeling	SUPPL	7	AP	2017-02-01	STANDARD
LABELING; Labeling	SUPPL	8	AP	2020-04-11	STANDARD
LABELING; Labeling	SUPPL	9	AP	2020-04-11	STANDARD
LABELING; Labeling	SUPPL	15	AP	2020-04-11	STANDARD

Submissions Property Types

ORIG	1	Null	19
SUPPL	2	Null	7
SUPPL	7	Null	7
SUPPL	8	Null	15
SUPPL	9	Null	15
SUPPL	15	Null	7

TE Codes

001

Prescription

AP

CDER Filings

SUN PHARM INDS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90923
            [companyName] => SUN PHARM INDS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"AZITHROMYCIN","activeIngredients":"AZITHROMYCIN","strength":"EQ 500MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AZITHROMYCIN","submission":"AZITHROMYCIN","actionType":"EQ 500MG BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)