ANDA 206994

DR REDDYS LABS LTD

FDA Drug Application

Application #206994

Application Sponsors

ANDA 206994

DR REDDYS LABS LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	CAPSULE;ORAL	8MCG	0	LUBIPROSTONE	LUBIPROSTONE
002	CAPSULE;ORAL	24MCG	0	LUBIPROSTONE	LUBIPROSTONE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-02-08

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

DR REDDYS LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206994
            [companyName] => DR REDDYS LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LUBIPROSTONE","activeIngredients":"LUBIPROSTONE","strength":"8MCG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LUBIPROSTONE","activeIngredients":"LUBIPROSTONE","strength":"24MCG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/08\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-02-08
        )

)