Documents
Application Sponsors
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Application Products
001 | INJECTABLE;INJECTION | 60MG/0.2ML | 0 | LANREOTIDE | LANREOTIDE |
002 | INJECTABLE;INJECTION | 90MG/0.3ML | 0 | LANREOTIDE | LANREOTIDE |
003 | INJECTABLE;INJECTION | 120MG/0.5ML | 0 | LANREOTIDE | LANREOTIDE |
FDA Submissions
TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 2021-12-17 | STANDARD |
Submissions Property Types
CDER Filings
INVAGEN PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 215395
[companyName] => INVAGEN PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"LANREOTIDE","activeIngredients":"LANREOTIDE","strength":"60MG\/0.2ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"LANREOTIDE","activeIngredients":"LANREOTIDE","strength":"90MG\/0.3ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"LANREOTIDE","activeIngredients":"LANREOTIDE","strength":"120MG\/0.5ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"12\/17\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/215395s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"12\/17\/2021","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\\\/2021\\\/215395s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/215395Orig1s000ltr.pdf\"}]","notes":">"}]
[supplements] =>
[actionDate] => 2021-12-17
)
)