Documents
Application Sponsors
| ANDA 091601 | TRIS PHARMA INC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | SOLUTION;ORAL | 5MG/5ML | 0 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE |
| 002 | SOLUTION;ORAL | 10MG/5ML | 0 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 2010-07-23 | |
| LABELING; Labeling | SUPPL | 2 | AP | 2022-09-06 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2022-09-06 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2022-09-06 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2022-09-06 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 1 |
| SUPPL | 2 | Null | 7 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 6 | Null | 15 |
| SUPPL | 10 | Null | 7 |
TE Codes
| 001 | Prescription | AA |
| 002 | Prescription | AA |
CDER Filings
TRIS PHARMA INC
cder:Array
(
[0] => Array
(
[ApplNo] => 91601
[companyName] => TRIS PHARMA INC
[docInserts] => ["",""]
[products] => [{"drugName":"METHYLPHENIDATE HYDROCHLORIDE","activeIngredients":"METHYLPHENIDATE HYDROCHLORIDE","strength":"5MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METHYLPHENIDATE HYDROCHLORIDE","activeIngredients":"METHYLPHENIDATE HYDROCHLORIDE","strength":"10MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"METHYLPHENIDATE HYDROCHLORIDE","submission":"METHYLPHENIDATE HYDROCHLORIDE","actionType":"5MG\/5ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"METHYLPHENIDATE HYDROCHLORIDE","submission":"METHYLPHENIDATE HYDROCHLORIDE","actionType":"10MG\/5ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)