Application Sponsors
ANDA 074393 | WATSON LABS INC | |
Marketing Status
Application Products
001 | LIQUID;INHALATION | 99.9% | 0 | ISOFLURANE | ISOFLURANE |
FDA Submissions
| ORIG | 1 | AP | 1995-05-12 | |
LABELING; Labeling | SUPPL | 2 | AP | 1996-03-25 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1996-09-19 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1997-04-03 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1997-04-03 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1999-04-23 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1999-04-23 | |
LABELING; Labeling | SUPPL | 8 | AP | 1999-04-23 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1999-04-23 | |
LABELING; Labeling | SUPPL | 10 | AP | 1999-07-27 | |
LABELING; Labeling | SUPPL | 11 | AP | 1999-11-10 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 2000-12-08 | |
Submissions Property Types
SUPPL | 1 | Null | 0 |
SUPPL | 3 | Null | 0 |
SUPPL | 4 | Null | 0 |
SUPPL | 5 | Null | 0 |
SUPPL | 6 | Null | 0 |
SUPPL | 7 | Null | 0 |
SUPPL | 9 | Null | 0 |
SUPPL | 12 | Null | 0 |
CDER Filings
WATSON LABS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 74393
[companyName] => WATSON LABS INC
[docInserts] => ["",""]
[products] => [{"drugName":"ISOFLURANE","activeIngredients":"ISOFLURANE","strength":"99.9%","dosageForm":"LIQUID;INHALATION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"ISOFLURANE","submission":"ISOFLURANE","actionType":"99.9%","submissionClassification":"LIQUID;INHALATION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)