Application Sponsors
| ANDA 062945 | WATSON LABS INC | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | EQ 10MG BASE/ML | 0 | TOBRAMYCIN SULFATE | TOBRAMYCIN SULFATE |
| 002 | INJECTABLE;INJECTION | EQ 40MG BASE/ML | 0 | TOBRAMYCIN SULFATE | TOBRAMYCIN SULFATE |
FDA Submissions
| ORIG | 1 | AP | 1989-08-09 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1991-05-10 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1991-05-31 | |
| LABELING; Labeling | SUPPL | 5 | AP | 1992-04-13 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1992-04-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1992-03-05 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1995-04-10 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1994-03-15 | |
| LABELING; Labeling | SUPPL | 10 | AP | 1994-06-17 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1995-10-27 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1995-11-01 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1996-07-11 | |
| LABELING; Labeling | SUPPL | 14 | AP | 1998-11-03 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 2000-04-28 | |
| LABELING; Labeling | SUPPL | 16 | AP | 2000-06-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 2000-12-08 | |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 17 | Null | 0 |
CDER Filings
WATSON LABS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 62945
[companyName] => WATSON LABS INC
[docInserts] => ["",""]
[products] => [{"drugName":"TOBRAMYCIN SULFATE","activeIngredients":"TOBRAMYCIN SULFATE","strength":"EQ 10MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TOBRAMYCIN SULFATE","activeIngredients":"TOBRAMYCIN SULFATE","strength":"EQ 40MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"TOBRAMYCIN SULFATE","submission":"TOBRAMYCIN SULFATE","actionType":"EQ 10MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"TOBRAMYCIN SULFATE","submission":"TOBRAMYCIN SULFATE","actionType":"EQ 40MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)