Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | EQ 50MG BASE/2ML (EQ 25MG BASE/ML) | 0 | METHOTREXATE SODIUM PRESERVATIVE FREE | METHOTREXATE SODIUM |
| 002 | INJECTABLE;INJECTION | EQ 250MG BASE/10ML (EQ 25MG BASE/ML) | 0 | METHOTREXATE SODIUM PRESERVATIVE FREE | METHOTREXATE SODIUM |
FDA Submissions
| ORIG | 1 | AP | 2009-03-31 | |
| LABELING; Labeling | SUPPL | 3 | AP | 2012-03-30 | |
| LABELING; Labeling | SUPPL | 13 | AP | 2021-10-25 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 2021-10-25 | STANDARD |
Submissions Property Types
| SUPPL | 3 | Null | 15 |
| SUPPL | 13 | Null | 15 |
| SUPPL | 14 | Null | 15 |
TE Codes
| 001 | Prescription | AP |
| 002 | Prescription | AP |
CDER Filings
SANDOZ INC
cder:Array
(
[0] => Array
(
[ApplNo] => 90039
[companyName] => SANDOZ INC
[docInserts] => ["",""]
[products] => [{"drugName":"METHOTREXATE SODIUM PRESERVATIVE FREE","activeIngredients":"METHOTREXATE SODIUM","strength":"EQ 50MG BASE\/2ML (EQ 25MG BASE\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METHOTREXATE SODIUM PRESERVATIVE FREE","activeIngredients":"METHOTREXATE SODIUM","strength":"EQ 250MG BASE\/10ML (EQ 25MG BASE\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"METHOTREXATE SODIUM PRESERVATIVE FREE","submission":"METHOTREXATE SODIUM","actionType":"EQ 50MG BASE\/2ML (EQ 25MG BASE\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"METHOTREXATE SODIUM PRESERVATIVE FREE","submission":"METHOTREXATE SODIUM","actionType":"EQ 250MG BASE\/10ML (EQ 25MG BASE\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)