ANDA 201835

SAGENT PHARMS INC

FDA Drug Application

Application #201835

Documents

• Review: 2020-10-06

Application Sponsors

ANDA 201835

SAGENT PHARMS INC

Marketing Status

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

Application Products

001	INJECTABLE;INJECTION	20MG/ML	0	METHYLPREDNISOLONE ACETATE	METHYLPREDNISOLONE ACETATE
002	INJECTABLE;INJECTION	40MG/ML	0	METHYLPREDNISOLONE ACETATE	METHYLPREDNISOLONE ACETATE
003	INJECTABLE;INJECTION	80MG/ML	0	METHYLPREDNISOLONE ACETATE	METHYLPREDNISOLONE ACETATE

FDA Submissions

N/A; Not Applicable

ORIG

1

AP

2018-06-27

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

SAGENT PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201835
            [companyName] => SAGENT PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHYLPREDNISOLONE ACETATE","activeIngredients":"METHYLPREDNISOLONE ACETATE","strength":"20MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METHYLPREDNISOLONE ACETATE","activeIngredients":"METHYLPREDNISOLONE ACETATE","strength":"40MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METHYLPREDNISOLONE ACETATE","activeIngredients":"METHYLPREDNISOLONE ACETATE","strength":"80MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/27\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/201835Orig1s000.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"08\/07\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-08-07
        )

)