ANDA 200926

SANDOZ INC

FDA Drug Application

Application #200926

Documents

• Letter: 2014-02-11

Application Sponsors

ANDA 200926

SANDOZ INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

4MCG/2ML (2MCG/ML)

0

DOXERCALCIFEROL

DOXERCALCIFEROL

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2014-02-04
LABELING; Labeling	SUPPL	4	AP	2016-10-13	STANDARD
LABELING; Labeling	SUPPL	5	AP	2019-08-22	STANDARD

Submissions Property Types

ORIG	1	Null	19
SUPPL	4	Null	15
SUPPL	5	Null	7

TE Codes

001

Prescription

AP

CDER Filings

SANDOZ INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200926
            [companyName] => SANDOZ INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOXERCALCIFEROL","activeIngredients":"DOXERCALCIFEROL","strength":"4MCG\/2ML (2MCG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/04\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/200926Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"08\/22\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/13\/2016","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/04\/2014","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-08-22
        )

)