ANDA 205980

MYLAN PHARMS INC

FDA Drug Application

Application #205980

Documents

• Letter: 2022-08-26

Application Sponsors

ANDA 205980

MYLAN PHARMS INC

Marketing Status

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

Application Products

002

TABLET; ORAL

EQ 2.5MG BASE

0

SAXAGLIPTIN HYDROCHLORIDE

SAXAGLIPTIN HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2022-04-22

STANDARD

Submissions Property Types

ORIG

1

Null

1

CDER Filings

MYLAN PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205980
            [companyName] => MYLAN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"SAXAGLIPTIN HYDROCHLORIDE","activeIngredients":"SAXAGLIPTIN HYDROCHLORIDE","strength":"EQ 5MG BASE","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"SAXAGLIPTIN HYDROCHLORIDE","activeIngredients":"SAXAGLIPTIN HYDROCHLORIDE","strength":"EQ 2.5MG BASE","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/22\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-04-22
        )

)