ANDA 207373

AMNEAL PHARMS LLC

FDA Drug Application

Application #207373

Application Sponsors

ANDA 207373

AMNEAL PHARMS LLC

Marketing Status

• Prescription: 001

Application Products

001

GEL, METERED;TRANSDERMAL

1.62% (20.25MG/1.25GM ACTUATION)

0

TESTOSTERONE

TESTOSTERONE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-04-10

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

AMNEAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207373
            [companyName] => AMNEAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"TESTOSTERONE","activeIngredients":"TESTOSTERONE","strength":"1.62% (20.25MG\/1.25GM ACTUATION)","dosageForm":"GEL, METERED;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/10\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"06\/21\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-06-21
        )

)