Application Sponsors
ANDA 210123 | GLAND PHARMA LTD | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | INJECTABLE;INJECTION | 500MG/10ML (50MG/ML) | 0 | FLUOROURACIL | FLUOROURACIL |
002 | INJECTABLE;INJECTION | 1GM/20ML (50MG/ML) | 0 | FLUOROURACIL | FLUOROURACIL |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2017-10-27 | STANDARD |
LABELING; Labeling | SUPPL | 4 | AP | 2022-09-14 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AP |
002 | Prescription | AP |
CDER Filings
GLAND PHARMA LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 210123
[companyName] => GLAND PHARMA LTD
[docInserts] => ["",""]
[products] => [{"drugName":"FLUOROURACIL","activeIngredients":"FLUOROURACIL","strength":"500MG\/10ML (50MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FLUOROURACIL","activeIngredients":"FLUOROURACIL","strength":"1GM\/20ML (50MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"10\/27\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2017-10-27
)
)