ANDA 202099

DR REDDYS LABS LTD

FDA Drug Application

Application #202099

Documents

• Other: 2015-07-02

Application Sponsors

ANDA 202099

DR REDDYS LABS LTD

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	CAPSULE;ORAL	10MG	0	ZENATANE	ISOTRETINOIN
002	CAPSULE;ORAL	20MG	0	ZENATANE	ISOTRETINOIN
003	CAPSULE;ORAL	40MG	0	ZENATANE	ISOTRETINOIN
004	CAPSULE;ORAL	30MG	0	ZENATANE	ISOTRETINOIN

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2013-03-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2015-02-23	UNKNOWN
REMS; REMS	SUPPL	4	AP	2015-09-03
REMS; REMS	SUPPL	5	AP	2016-02-04
REMS; REMS	SUPPL	7	AP	2016-07-08
REMS; REMS	SUPPL	9	AP	2017-06-17
LABELING; Labeling	SUPPL	11	AP	2018-05-02	STANDARD
REMS; REMS	SUPPL	12	AP	2018-04-23
LABELING; Labeling	SUPPL	15	AP	2018-08-31	STANDARD
LABELING; Labeling	SUPPL	20	AP	2020-11-16	STANDARD
REMS; REMS	SUPPL	21	AP	2020-12-09
LABELING; Labeling	SUPPL	23	AP	2021-11-09	STANDARD
REMS; REMS	SUPPL	24	AP	2021-10-08
LABELING; Labeling	SUPPL	28	AP	2022-08-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	2022-08-04	UNKNOWN
REMS; REMS	SUPPL	31	AP	2022-10-06

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	4	Null	15
SUPPL	5	Null	15
SUPPL	7	Null	15
SUPPL	9	Null	31
SUPPL	11	Null	15
SUPPL	12	Null	15
SUPPL	15	Null	7
SUPPL	20	Null	15
SUPPL	21	Null	7
SUPPL	23	Null	15
SUPPL	24	Null	15
SUPPL	28	Null	15
SUPPL	29	Null	15
SUPPL	31	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB

CDER Filings

DR REDDYS LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202099
            [companyName] => DR REDDYS LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZENATANE","activeIngredients":"ISOTRETINOIN","strength":"10MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ZENATANE","activeIngredients":"ISOTRETINOIN","strength":"20MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ZENATANE","activeIngredients":"ISOTRETINOIN","strength":"40MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ZENATANE","activeIngredients":"ISOTRETINOIN","strength":"30MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/25\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"08\/31\/2018","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/23\/2018","submission":"SUPPL-12","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/02\/2018","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/17\/2017","submission":"SUPPL-9","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/08\/2016","submission":"SUPPL-7","supplementCategories":"REMS-Modified","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/04\/2016","submission":"SUPPL-5","supplementCategories":"REMS-Modified","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/03\/2015","submission":"SUPPL-4","supplementCategories":"REMS-Modified","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/23\/2015","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert, REMS-Modified, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-08-31
        )

)