ANDA 214752

AMNEAL PHARMS NY

FDA Drug Application

Application #214752

Documents

• Letter: 2022-01-12

Application Sponsors

ANDA 214752

AMNEAL PHARMS NY

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION; OPHTHALMIC

1%

0

ATROPINE SULFATE

ATROPINE SULFATE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2021-12-09

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001

Prescription

AT

CDER Filings

AMNEAL PHARMS NY

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214752
            [companyName] => AMNEAL PHARMS NY
            [docInserts] => ["",""]
            [products] => [{"drugName":"ATROPINE SULFATE","activeIngredients":"ATROPINE SULFATE","strength":"1%","dosageForm":"SOLUTION; OPHTHALMIC","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/09\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/214752Orig1s000TA_ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-12-09
        )

)