ANDA 091186

DR REDDYS LABS LTD

FDA Drug Application

Application #091186

Application Sponsors

ANDA 091186

DR REDDYS LABS LTD

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRAVENOUS

EQ 4MG BASE/5ML

0

ZOLEDRONIC ACID

ZOLEDRONIC ACID

FDA Submissions

	ORIG	1	AP	2013-03-04
LABELING; Labeling	SUPPL	2	AP	2015-03-06	STANDARD
LABELING; Labeling	SUPPL	3	AP	2015-03-06	STANDARD
LABELING; Labeling	SUPPL	5	AP	2015-03-06	STANDARD
LABELING; Labeling	SUPPL	6	AP	2015-09-21	STANDARD
LABELING; Labeling	SUPPL	8	AP	2016-07-11	STANDARD
LABELING; Labeling	SUPPL	10	AP	2020-02-21	STANDARD
LABELING; Labeling	SUPPL	11	AP	2020-02-21	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7
SUPPL	3	Null	7
SUPPL	5	Null	7
SUPPL	6	Null	7
SUPPL	8	Null	7
SUPPL	10	Null	7
SUPPL	11	Null	7

TE Codes

001

Prescription

AP

CDER Filings

DR REDDYS LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91186
            [companyName] => DR REDDYS LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZOLEDRONIC ACID","activeIngredients":"ZOLEDRONIC ACID","strength":"EQ 4MG BASE\/5ML","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ZOLEDRONIC ACID","submission":"ZOLEDRONIC ACID","actionType":"EQ 4MG BASE\/5ML","submissionClassification":"INJECTABLE;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)