NDA 206966

DR REDDYS LABS SA

FDA Drug Application

Application #206966

Documents

• Label: 2020-07-24
• Letter: 2020-07-27
• Review: 2020-08-21
• Letter: 2022-07-21
• Label: 2022-07-25

Application Sponsors

NDA 206966

DR REDDYS LABS SA

Marketing Status

• Prescription: 001

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

ORIG	1	Null	7
SUPPL	2	Null	15

TE Codes

001

Prescription

TBD

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
        )

)