Documents
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
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
)
)