Application Sponsors
ANDA 074768 | BAXTER HLTHCARE CORP | |
Marketing Status
Application Products
001 | INJECTABLE;INJECTION | 10MG/ML | 0 | ATRACURIUM BESYLATE PRESERVATIVE FREE | ATRACURIUM BESYLATE |
FDA Submissions
| ORIG | 1 | AP | 1997-01-23 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1999-11-22 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1999-11-22 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1999-11-22 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 2000-02-17 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 2000-02-17 | |
Submissions Property Types
ORIG | 1 | Null | 0 |
SUPPL | 2 | Null | 0 |
SUPPL | 3 | Null | 0 |
SUPPL | 4 | Null | 0 |
SUPPL | 5 | Null | 0 |
SUPPL | 6 | Null | 0 |
CDER Filings
BAXTER HLTHCARE CORP
cder:Array
(
[0] => Array
(
[ApplNo] => 74768
[companyName] => BAXTER HLTHCARE CORP
[docInserts] => ["",""]
[products] => [{"drugName":"ATRACURIUM BESYLATE PRESERVATIVE FREE","activeIngredients":"ATRACURIUM BESYLATE","strength":"10MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"ATRACURIUM BESYLATE PRESERVATIVE FREE","submission":"ATRACURIUM BESYLATE","actionType":"10MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)