ANDA 208302

SHILPA MEDICARE LTD

FDA Drug Application

Application #208302

Application Sponsors

ANDA 208302

SHILPA MEDICARE LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	EQ 100MG BASE	0	IMATINIB MESYLATE	IMATINIB MESYLATE
002	TABLET;ORAL	EQ 400MG BASE	0	IMATINIB MESYLATE	IMATINIB MESYLATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-01-17

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

SHILPA MEDICARE LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208302
            [companyName] => SHILPA MEDICARE LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"IMATINIB MESYLATE","activeIngredients":"IMATINIB MESYLATE","strength":"EQ 100MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"IMATINIB MESYLATE","activeIngredients":"IMATINIB MESYLATE","strength":"EQ 400MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/17\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-01-17
        )

)