Application Sponsors
| ANDA 064052 | BAUSCH AND LOMB | |
Marketing Status
Application Products
| 001 | SOLUTION/DROPS;OPHTHALMIC | 0.3% | 0 | TOBRAMYCIN | TOBRAMYCIN |
FDA Submissions
| ORIG | 1 | AP | 1993-11-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1994-03-10 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1995-04-26 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1995-04-26 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1998-10-13 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1996-08-26 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1998-01-21 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1998-10-13 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1998-11-19 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1999-06-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 2000-05-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 2000-04-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 2000-07-03 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 2000-05-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 2000-06-27 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 2000-10-05 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 2001-03-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 2001-11-27 | |
| LABELING; Labeling | SUPPL | 32 | AP | 2020-05-08 | STANDARD |
| LABELING; Labeling | SUPPL | 38 | AP | 2021-06-21 | STANDARD |
| LABELING; Labeling | SUPPL | 39 | AP | 2021-06-21 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 32 | Null | 15 |
| SUPPL | 38 | Null | 7 |
| SUPPL | 39 | Null | 7 |
TE Codes
CDER Filings
BAUSCH AND LOMB
cder:Array
(
[0] => Array
(
[ApplNo] => 64052
[companyName] => BAUSCH AND LOMB
[docInserts] => ["",""]
[products] => [{"drugName":"TOBRAMYCIN","activeIngredients":"TOBRAMYCIN","strength":"0.3%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"TOBRAMYCIN","submission":"TOBRAMYCIN","actionType":"0.3%","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)