Application Sponsors
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | SOLUTION;INTRAVENOUS | 5MG/10ML (0.5MG/ML) | 0 | NEOSTIGMINE METHYLSULFATE | NEOSTIGMINE METHYLSULFATE |
002 | SOLUTION;INTRAVENOUS | 10MG/10ML (1MG/ML) | 0 | NEOSTIGMINE METHYLSULFATE | NEOSTIGMINE METHYLSULFATE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2018-06-15 | STANDARD |
LABELING; Labeling | SUPPL | 4 | AP | 2022-05-05 | STANDARD |
LABELING; Labeling | SUPPL | 5 | AP | 2022-11-16 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 15 |
SUPPL | 4 | Null | 7 |
SUPPL | 5 | Null | 7 |
TE Codes
001 | Prescription | AP |
002 | Prescription | AP |
CDER Filings
AMNEAL
cder:Array
(
[0] => Array
(
[ApplNo] => 210051
[companyName] => AMNEAL
[docInserts] => ["",""]
[products] => [{"drugName":"NEOSTIGMINE METHYLSULFATE","activeIngredients":"NEOSTIGMINE METHYLSULFATE","strength":"5MG\/10ML (0.5MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NEOSTIGMINE METHYLSULFATE","activeIngredients":"NEOSTIGMINE METHYLSULFATE","strength":"10MG\/10ML (1MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"06\/15\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2018-06-15
)
)