Application Sponsors
| ANDA 210484 | NOSTRUM LABS INC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | 5MG | 0 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE |
| 002 | TABLET;ORAL | 10MG | 0 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2018-08-02 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2021-02-16 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2021-02-16 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2021-06-02 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 2 | Null | 15 |
| SUPPL | 5 | Null | 7 |
| SUPPL | 6 | Null | 15 |
TE Codes
| 001 | Prescription | AA |
| 002 | Prescription | AA |
CDER Filings
NOSTRUM LABS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 210484
[companyName] => NOSTRUM LABS INC
[docInserts] => ["",""]
[products] => [{"drugName":"METHADONE HYDROCHLORIDE","activeIngredients":"METHADONE HYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METHADONE HYDROCHLORIDE","activeIngredients":"METHADONE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"08\/02\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"02\/16\/2021","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/16\/2021","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert, Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/18\/2018","submission":"SUPPL-1","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2021-02-16
)
)