ANDA 208657

DR REDDYS LABS LTD

FDA Drug Application

Application #208657

Documents

• Review: 2020-03-19

Application Sponsors

ANDA 208657

DR REDDYS LABS LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE, LIPOSOMAL;INJECTION	20MG/10ML (2MG/ML)	0	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	DOXORUBICIN HYDROCHLORIDE
002	INJECTABLE, LIPOSOMAL;INJECTION	50MG/25ML (2MG/ML)	0	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	DOXORUBICIN HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-05-15	STANDARD
LABELING; Labeling	SUPPL	4	AP	2020-06-26	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	4	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

DR REDDYS LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208657
            [companyName] => DR REDDYS LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)","activeIngredients":"DOXORUBICIN HYDROCHLORIDE","strength":"20MG\/10ML (2MG\/ML)","dosageForm":"INJECTABLE, LIPOSOMAL;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)","activeIngredients":"DOXORUBICIN HYDROCHLORIDE","strength":"50MG\/25ML (2MG\/ML)","dosageForm":"INJECTABLE, LIPOSOMAL;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/15\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/208657Orig1s000.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"06\/26\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/03\/2017","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-06-26
        )

)