NDA 216318

SLAYBACK PHARMA LLC

FDA Drug Application

Application #216318

Documents

• Letter: 2022-06-03
• Label: 2022-06-03
• Medication Guide: 2022-06-03

Application Sponsors

NDA 216318

SLAYBACK PHARMA LLC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

200MG/ML

0

TESTOSTERONE CYPIONATE

TESTOSTERONE CYPIONATE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2022-06-02

STANDARD

Submissions Property Types

ORIG

1

Null

6

CDER Filings

SLAYBACK PHARMA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216318
            [companyName] => SLAYBACK PHARMA LLC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2022\/216318s000lbl.pdf#page=14"]
            [products] => [{"drugName":"TESTOSTERONE CYPIONATE","activeIngredients":"TESTOSTERONE CYPIONATE","strength":"200MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"06\/02\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/216318s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"06\/02\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/216318s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/216318Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-06-02
        )

)