ANDA 208427

DR REDDYS LABS LTD

FDA Drug Application

Application #208427

Documents

• Letter: 2021-03-10

Application Sponsors

ANDA 208427

DR REDDYS LABS LTD

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002
• None (Tentative Approval): 003

Application Products

001	UNKNOWN	UNKNOWN	0	LINAGLIPTIN; METFORMIN HYDROCHLORIDE	LINAGLIPTIN;METFORMIN HYDROCHLORIDE
002	TABLET;ORAL	2.5MG; 850MG	0	LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	LINAGLIPTIN; METFORMIN HYDROCHLORIDE
003	TABLET;ORAL	2.5MG; 1G	0	LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	LINAGLIPTIN; METFORMIN HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2021-02-01

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

DR REDDYS LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208427
            [companyName] => DR REDDYS LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LINAGLIPTIN; METFORMIN HYDROCHLORIDE","activeIngredients":"LINAGLIPTIN;METFORMIN HYDROCHLORIDE","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/01\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-02-01
        )

)