ANDA 214293

AMNEAL PHARMS NY

FDA Drug Application

Application #214293

Documents

• Letter: 2021-12-20
• Letter: 2022-08-25

Application Sponsors

ANDA 214293

AMNEAL PHARMS NY

Marketing Status

• None (Tentative Approval): 001

Application Products

001

CAPSULE;ORAL

1MG;100MG

0

ESTRADIOL AND PROGESTERONE

ESTRADIOL; PROGESTERONE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2021-11-09

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001

Prescription

AB

CDER Filings

AMNEAL PHARMS NY

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214293
            [companyName] => AMNEAL PHARMS NY
            [docInserts] => ["",""]
            [products] => [{"drugName":"ESTRADIOL; PROGESTERONE","activeIngredients":"ESTRADIOL;PROGESTERONE","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/09\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-11-09
        )

)