ANDA 200271

ASPEN GLOBAL INC

FDA Drug Application

Application #200271

Documents

• Label: 2015-10-02
• Letter: 2015-09-16

Application Sponsors

ANDA 200271

ASPEN GLOBAL INC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INTRAMUSCULAR

1250MG/5ML (250MG/ML)

0

HYDROXYPROGESTERONE CAPROATE

HYDROXYPROGESTERONE CAPROATE

FDA Submissions

N/A; Not Applicable

ORIG

1

AP

2015-08-24

Submissions Property Types

ORIG

1

Null

15

CDER Filings

ASPEN GLOBAL INC

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(
    [0] => Array
        (
            [ApplNo] => 200271
            [companyName] => ASPEN GLOBAL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROXYPROGESTERONE CAPROATE","activeIngredients":"HYDROXYPROGESTERONE CAPROATE","strength":"1250MG\/5ML (250MG\/ML)","dosageForm":"SOLUTION;INTRAMUSCULAR","marketingStatus":"Prescription","te":"None","rld":"No","rs":"Yes"}]
            [labels] => [{"actionDate":"08\/24\/2015","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/200271lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"08\/24\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/200271lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/200271Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2015-08-24
        )

)