ANDA 207324

GLAND PHARMA LTD

FDA Drug Application

Application #207324

Application Sponsors

ANDA 207324

GLAND PHARMA LTD

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	INJECTABLE;IV (INFUSION)	50MG/5ML (10MG/ML)	0	CARBOPLATIN	CARBOPLATIN
002	INJECTABLE;INTRAVENOUS	150MG/15ML (10MG/ML)	0	CARBOPLATIN	CARBOPLATIN
003	INJECTABLE;INTRAVENOUS	450MG/45ML (10MG/ML)	0	CARBOPLATIN	CARBOPLATIN
004	INJECTABLE;INTRAVENOUS	600MG/60ML (10MG/ML)	0	CARBOPLATIN	CARBOPLATIN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-02-15

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AP
002	Prescription	AP
003	Prescription	AP
004	Prescription	AP

CDER Filings

GLAND PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207324
            [companyName] => GLAND PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"CARBOPLATIN","activeIngredients":"CARBOPLATIN","strength":"50MG\/5ML (10MG\/ML)","dosageForm":"INJECTABLE;IV (INFUSION)","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CARBOPLATIN","activeIngredients":"CARBOPLATIN","strength":"150MG\/15ML (10MG\/ML)","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CARBOPLATIN","activeIngredients":"CARBOPLATIN","strength":"450MG\/45ML (10MG\/ML)","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CARBOPLATIN","activeIngredients":"CARBOPLATIN","strength":"600MG\/60ML (10MG\/ML)","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/15\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-02-15
        )

)