DR REDDYS LABS LTD FDA Approval ANDA 091363

ANDA 091363

DR REDDYS LABS LTD

FDA Drug Application

Application #091363

Documents

Review2013-05-02

Application Sponsors

ANDA 091363DR REDDYS LABS LTD

Marketing Status

Prescription001

Application Products

001INJECTABLE;INTRAVENOUSEQ 5MG BASE/100ML0ZOLEDRONIC ACIDZOLEDRONIC ACID

FDA Submissions

ORIG1AP2013-03-29
LABELING; LabelingSUPPL4AP2015-09-02STANDARD
LABELING; LabelingSUPPL6AP2017-09-18STANDARD

Submissions Property Types

ORIG1Null42
SUPPL4Null7
SUPPL6Null15

TE Codes

001PrescriptionAP

CDER Filings

DR REDDYS LABS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91363
            [companyName] => DR REDDYS LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZOLEDRONIC ACID","activeIngredients":"ZOLEDRONIC ACID","strength":"EQ 5MG BASE\/100ML","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ZOLEDRONIC ACID","submission":"ZOLEDRONIC ACID","actionType":"EQ 5MG BASE\/100ML","submissionClassification":"INJECTABLE;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.