ANDA 208620

DR REDDYS

FDA Drug Application

Application #208620

Documents

• Letter: 2018-01-08
• Letter: 2018-05-11
• Letter: 2018-09-14
• Letter: 2018-10-15
• Letter: 2019-02-21

Application Sponsors

ANDA 208620

DR REDDYS

Marketing Status

• Prescription: 001

Application Products

001

GEL, METERED;TRANSDERMAL

1.62% (20.25MG/1.25GM ACTUATION)

0

TESTOSTERONE

TESTOSTERONE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-04-10	STANDARD
LABELING; Labeling	SUPPL	2	AP	2019-06-04	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7

TE Codes

001

Prescription

AB

CDER Filings

DR REDDYS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208620
            [companyName] => DR REDDYS
            [docInserts] => ["",""]
            [products] => [{"drugName":"TESTOSTERONE","activeIngredients":"TESTOSTERONE","strength":"1.62% (20.25MG\/1.25GM ACTUATION)","dosageForm":"GEL, METERED;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/10\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/208620Orig1s000TAltr.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/208620Orig1s000TAltr.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/208620Orig1s000ReplacementTAltr.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/208620Orig1s000TALtr_Corrrected.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/208620Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"06\/04\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/04\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-06-04
        )

)