NDA 205054

GP-PHARM SA

FDA Drug Application

Application #205054

Documents

• Letter: 2018-09-18
• Label: 2018-10-22
• Review: 2019-04-04

Application Sponsors

NDA 205054

GP-PHARM SA

Marketing Status

• Discontinued: 001

Application Products

001

FOR SUSPENSION;INTRAMUSCULAR

22.5MG/VIAL

1

LUTRATE DEPOT KIT

LEUPROLIDE ACETATE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2018-08-28

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

GP-PHARM SA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205054
            [companyName] => GP-PHARM SA
            [docInserts] => ["",""]
            [products] => [{"drugName":"LUTRATE DEPOT KIT","activeIngredients":"LEUPROLIDE ACETATE","strength":"22.5MG\/VIAL","dosageForm":"FOR SUSPENSION;INTRAMUSCULAR","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"08\/28\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/205054s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"08\/28\/2018","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\\\/2018\\\/205054s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/205054Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/205054Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2018-08-28
        )

)