Documents
Application Sponsors
ANDA 202053 | WATSON LABS INC | |
Marketing Status
Application Products
001 | SOLUTION/DROPS;OPHTHALMIC | EQ 2% BASE | 0 | DORZOLAMIDE HYDROCHLORIDE | DORZOLAMIDE HYDROCHLORIDE |
FDA Submissions
N/A; Not Applicable | ORIG | 1 | AP | 2014-09-11 | |
Submissions Property Types
TE Codes
CDER Filings
INDOCO
cder:Array
(
[0] => Array
(
[ApplNo] => 202053
[companyName] => INDOCO
[docInserts] => ["",""]
[products] => [{"drugName":"DORZOLAMIDE HYDROCHLORIDE","activeIngredients":"DORZOLAMIDE HYDROCHLORIDE","strength":"EQ 2% BASE","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"09\/11\/2014","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/202053Orig1s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"09\/11\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/202053Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/202053Orig1s000ltr.pdf\"}]","notes":">"}]
[supplements] =>
[actionDate] => 2014-09-11
)
)