ANDA 210761

SUN PHARM

FDA Drug Application

Application #210761

Documents

• Letter: 2019-04-29

Application Sponsors

ANDA 210761

SUN PHARM

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

150MG/ML

0

MEDROXYPROGESTERONE ACETATE

MEDROXYPROGESTERONE ACETATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-04-24	STANDARD
LABELING; Labeling	SUPPL	8	AP	2021-06-22	STANDARD
LABELING; Labeling	SUPPL	9	AP	2021-06-22	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	8	Null	7
SUPPL	9	Null	7

TE Codes

001

Prescription

AB

CDER Filings

SUN PHARM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210761
            [companyName] => SUN PHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"MEDROXYPROGESTERONE ACETATE","activeIngredients":"MEDROXYPROGESTERONE ACETATE","strength":"150MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/24\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/210761Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-04-24
        )

)