Documents
Application Sponsors
| ANDA 090180 | NOSTRUM LABS INC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | SYRUP;ORAL | 10MG/5ML;6.25MG/5ML | 0 | PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE | CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE |
| 002 | SYRUP; ORAL | 10MG; 5ML | 0 | PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE | PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE |
FDA Submissions
| ORIG | 1 | AP | 2010-03-17 | |
| LABELING; Labeling | SUPPL | 5 | AP | 2013-05-10 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2017-01-13 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2017-08-29 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2018-06-28 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 42 |
| SUPPL | 5 | Null | 15 |
| SUPPL | 6 | Null | 15 |
| SUPPL | 7 | Null | 7 |
| SUPPL | 8 | Null | 7 |
TE Codes
CDER Filings
NOSTRUM LABS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 90180
[companyName] => NOSTRUM LABS INC
[docInserts] => ["",""]
[products] => [{"drugName":"PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE","activeIngredients":"CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE","strength":"10MG\/5ML;6.25MG\/5ML","dosageForm":"SYRUP;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE","activeIngredients":"PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE","strength":"10MG; 5ML","dosageForm":"SYRUP; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE","submission":"CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE","actionType":"10MG\/5ML;6.25MG\/5ML","submissionClassification":"SYRUP;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE","submission":"PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE","actionType":"10MG; 5ML","submissionClassification":"SYRUP; ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)