Documents
Application Sponsors
NDA 206966 | DR REDDYS LABS SA | |
Marketing Status
Application Products
001 | LOTION;TOPICAL | 0.74% | 2 | XEGLYZE | ABAMETAPIR |
FDA Submissions
TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2020-07-24 | STANDARD |
LABELING; Labeling | SUPPL | 2 | AP | 2022-07-20 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
DR REDDYS LABS SA
cder:Array
(
[0] => Array
(
[ApplNo] => 206966
[companyName] => DR REDDYS LABS SA
[docInserts] => ["",""]
[products] => [{"drugName":"XEGLYZE","activeIngredients":"ABAMETAPIR","strength":"0.74%","dosageForm":"LOTION;TOPICAL","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"}]
[labels] => [{"actionDate":"07\/24\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/206966lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"07\/24\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/206966lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/206966Orig1s000ltr.pdf\"}]","notes":">"}]
[supplements] =>
[actionDate] => 2020-07-24
)
)