Documents
Application Sponsors
ANDA 064206 | WATSON LABS INC | |
Marketing Status
Application Products
001 | FOR SUSPENSION;ORAL | EQ 250MG BASE/5ML | 0 | CEFACLOR | CEFACLOR |
FDA Submissions
| ORIG | 1 | AP | 1998-02-18 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1999-03-05 | |
LABELING; Labeling | SUPPL | 4 | AP | 1999-05-03 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 2000-12-08 | |
Submissions Property Types
SUPPL | 1 | Null | 0 |
SUPPL | 3 | Null | 0 |
SUPPL | 5 | Null | 0 |
CDER Filings
WATSON LABS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 64206
[companyName] => WATSON LABS INC
[docInserts] => ["",""]
[products] => [{"drugName":"CEFACLOR","activeIngredients":"CEFACLOR","strength":"EQ 250MG BASE\/5ML","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"CEFACLOR","submission":"CEFACLOR","actionType":"EQ 250MG BASE\/5ML","submissionClassification":"FOR SUSPENSION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)