Documents
Application Sponsors
ANDA 209921 | ANI PHARMS INC | |
Marketing Status
Application Products
001 | CAPSULE;ORAL | 250MG | 0 | PENICILLAMINE | PENICILLAMINE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2019-05-07 | STANDARD |
LABELING; Labeling | SUPPL | 6 | AP | 2021-08-27 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
ANI PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 209921
[companyName] => ANI PHARMS INC
[docInserts] => ["",""]
[products] => [{"drugName":"PENICILLAMINE","activeIngredients":"PENICILLAMINE","strength":"250MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"05\/07\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/209921Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2019-05-07
)
)