ANDA 090802

PANACEA BIOTEC LTD

FDA Drug Application

Application #090802

Application Sponsors

ANDA 090802

PANACEA BIOTEC LTD

Marketing Status

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

Application Products

001	CAPSULE;ORAL	EQ 0.5MG BASE	0	TACROLIMUS	TACROLIMUS
002	CAPSULE;ORAL	EQ 1MG BASE	0	TACROLIMUS	TACROLIMUS
003	CAPSULE;ORAL	EQ 5MG BASE	0	TACROLIMUS	TACROLIMUS

FDA Submissions

	ORIG	1	AP	2012-09-28
LABELING; Labeling	SUPPL	7	AP	2019-11-18	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	7	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

PANACEA BIOTEC LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90802
            [companyName] => PANACEA BIOTEC LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"TACROLIMUS","activeIngredients":"TACROLIMUS","strength":"EQ 0.5MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TACROLIMUS","activeIngredients":"TACROLIMUS","strength":"EQ 1MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TACROLIMUS","activeIngredients":"TACROLIMUS","strength":"EQ 5MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TACROLIMUS","submission":"TACROLIMUS","actionType":"EQ 0.5MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"TACROLIMUS","submission":"TACROLIMUS","actionType":"EQ 1MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"TACROLIMUS","submission":"TACROLIMUS","actionType":"EQ 5MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)