ANDA 203563

SANDOZ INC

FDA Drug Application

Application #203563

Documents

• Letter: 2015-03-11
• Letter: 2015-03-11
• Label: 2015-03-12

Application Sponsors

ANDA 203563

SANDOZ INC

Marketing Status

• Prescription: 001
• Discontinued: 002

Application Products

001	SOLUTION;INTRAVENOUS	EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)	0	LEVOLEUCOVORIN CALCIUM	LEVOLEUCOVORIN CALCIUM
002	SOLUTION;INTRAVENOUS	EQ 250MG BASE/25ML (EQ 10MG BASE/ML)	0	LEVOLEUCOVORIN CALCIUM	LEVOLEUCOVORIN CALCIUM

FDA Submissions

UNKNOWN;	ORIG	1	AP	2015-03-09
LABELING; Labeling	SUPPL	4	AP	2017-01-06	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	4	Null	15

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

SANDOZ INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203563
            [companyName] => SANDOZ INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVOLEUCOVORIN CALCIUM","activeIngredients":"LEVOLEUCOVORIN CALCIUM","strength":"EQ 175MG BASE\/17.5ML (EQ 10MG BASE\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVOLEUCOVORIN CALCIUM","activeIngredients":"LEVOLEUCOVORIN CALCIUM","strength":"EQ 250MG BASE\/25ML (EQ 10MG BASE\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"03\/09\/2015","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/203563Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"03\/09\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/203563Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/203563Orig1s000ltr.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/203563Orig1s000TAltr.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"01\/06\/2017","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2017-01-06
        )

)