Documents
Application Sponsors
ANDA 202054 | WATSON LABS INC | |
Marketing Status
Application Products
001 | SOLUTION/DROPS;OPHTHALMIC | EQ 2% BASE;EQ 0.5% BASE | 0 | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE |
FDA Submissions
N/A; Not Applicable | ORIG | 1 | AP | 2014-09-03 | |
LABELING; Labeling | SUPPL | 2 | AP | 2021-02-10 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
INDOCO
cder:Array
(
[0] => Array
(
[ApplNo] => 202054
[companyName] => INDOCO
[docInserts] => ["",""]
[products] => [{"drugName":"DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE","activeIngredients":"DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE","strength":"EQ 2% BASE;EQ 0.5% BASE","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"09\/03\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/202054Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2014-09-03
)
)