Application Sponsors
ANDA 203447 | ANI PHARMS INC | |
Marketing Status
Application Products
001 | SOLUTION;ORAL | 100MG/5ML | 0 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2017-08-30 | STANDARD |
REMS; REMS | SUPPL | 2 | AP | 2018-09-18 | |
LABELING; Labeling | SUPPL | 4 | AP | 2020-03-04 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 7 |
SUPPL | 2 | Null | 15 |
SUPPL | 4 | Null | 15 |
CDER Filings
ANI PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 203447
[companyName] => ANI PHARMS INC
[docInserts] => ["",""]
[products] => [{"drugName":"OXYCODONE HYDROCHLORIDE","activeIngredients":"OXYCODONE HYDROCHLORIDE","strength":"100MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"08\/30\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"03\/04\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/18\/2018","submission":"SUPPL-2","supplementCategories":"REMS - PROPOSAL - D-N-A","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-03-04
)
)