Documents
Application Sponsors
NDA 206927 | DR REDDYS LABS LTD | |
Marketing Status
Application Products
001 | POWDER;INTRAVENOUS | 3.5MG/VIAL | 0 | BORTEZOMIB | BORTEZOMIB |
FDA Submissions
TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 2019-10-04 | STANDARD |
LABELING; Labeling | SUPPL | 2 | AP | 2022-02-28 | STANDARD |
Submissions Property Types
CDER Filings
DR REDDYS LABS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 206927
[companyName] => DR REDDYS LABS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"BORTEZOMIB","activeIngredients":"BORTEZOMIB","strength":"3.5MG\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"10\/04\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/206927s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"10\/04\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/206927s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/206927Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/206927Orig1s000TOC.cfm\"}]","notes":">"}]
[supplements] =>
[actionDate] => 2019-10-04
)
)