Application Sponsors
ANDA 201006 | BAUSCH AND LOMB | |
Marketing Status
Application Products
001 | SOLUTION/DROPS;OPHTHALMIC | 0.005% | 0 | LATANOPROST | LATANOPROST |
FDA Submissions
N/A; Not Applicable | ORIG | 1 | AP | 2011-03-22 | |
LABELING; Labeling | SUPPL | 4 | AP | 2013-02-27 | STANDARD |
LABELING; Labeling | SUPPL | 6 | AP | 2015-12-09 | STANDARD |
LABELING; Labeling | SUPPL | 8 | AP | 2020-02-21 | STANDARD |
LABELING; Labeling | SUPPL | 13 | AP | 2021-09-03 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 7 |
SUPPL | 4 | Null | 15 |
SUPPL | 6 | Null | 7 |
SUPPL | 8 | Null | 7 |
SUPPL | 13 | Null | 7 |
TE Codes
CDER Filings
BAUSCH AND LOMB
cder:Array
(
[0] => Array
(
[ApplNo] => 201006
[companyName] => BAUSCH AND LOMB
[docInserts] => ["",""]
[products] => [{"drugName":"LATANOPROST","activeIngredients":"LATANOPROST","strength":"0.005%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"03\/22\/2011","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"02\/21\/2020","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/09\/2015","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/27\/2013","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-02-21
)
)