ANDA 205749

GLAND PHARMA LTD

FDA Drug Application

Application #205749

Application Sponsors

ANDA 205749

GLAND PHARMA LTD

Marketing Status

• Prescription: 001
• None (Tentative Approval): 002

Application Products

001	INJECTABLE;INTRAVENOUS	EQ 4MG BASE/100ML	0	ZOLEDRONIC	ZOLEDRONIC ACID
002	INJECTABLE;IV (INFUSION)	EQ 4MG BASE/100ML	0	ZOLEDRONIC ACID	ZOLEDRONIC ACID

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-06-29

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AP

CDER Filings

GLAND PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205749
            [companyName] => GLAND PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZOLEDRONIC","activeIngredients":"ZOLEDRONIC ACID","strength":"EQ 4MG BASE\/100ML","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ZOLEDRONIC ACID","activeIngredients":"ZOLEDRONIC ACID","strength":"EQ 4MG BASE\/100ML","dosageForm":"INJECTABLE;IV (INFUSION)","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/29\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-06-29
        )

)