ANDA 091693

DR REDDYS LABS SA

FDA Drug Application

Application #091693

Application Sponsors

ANDA 091693

DR REDDYS LABS SA

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

8MG

0

RAMELTEON

RAMELTEON

FDA Submissions

	ORIG	1	AP	2013-07-26
LABELING; Labeling	SUPPL	2	AP	2020-02-07	STANDARD
LABELING; Labeling	SUPPL	3	AP	2022-06-30	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7
SUPPL	3	Null	15

TE Codes

001

Prescription

AB

CDER Filings

DR REDDYS LABS SA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91693
            [companyName] => DR REDDYS LABS SA
            [docInserts] => ["",""]
            [products] => [{"drugName":"RAMELTEON","activeIngredients":"RAMELTEON","strength":"8MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"RAMELTEON","submission":"RAMELTEON","actionType":"8MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)