Application Sponsors
| NDA 008248 | BAXTER HLTHCARE CORP | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | EQ 30MG BASE/ML | 0 | WYAMINE SULFATE | MEPHENTERMINE SULFATE |
| 002 | INJECTABLE;INJECTION | EQ 15MG BASE/ML | 0 | WYAMINE SULFATE | MEPHENTERMINE SULFATE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1951-12-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1978-06-07 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 1993-02-17 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1985-10-23 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 1988-05-31 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | Null | 0 |
CDER Filings
BAXTER HLTHCARE CORP
cder:Array
(
[0] => Array
(
[ApplNo] => 8248
[companyName] => BAXTER HLTHCARE CORP
[docInserts] => ["",""]
[products] => [{"drugName":"WYAMINE SULFATE","activeIngredients":"MEPHENTERMINE SULFATE","strength":"EQ 30MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"WYAMINE SULFATE","activeIngredients":"MEPHENTERMINE SULFATE","strength":"EQ 15MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"WYAMINE SULFATE","submission":"MEPHENTERMINE SULFATE","actionType":"EQ 30MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"WYAMINE SULFATE","submission":"MEPHENTERMINE SULFATE","actionType":"EQ 15MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)