Documents
Application Sponsors
ANDA 202503 | WATSON LABS INC | |
Marketing Status
Application Products
001 | TABLET;ORAL | EQ 20MG BASE | 0 | SILDENAFIL CITRATE | SILDENAFIL CITRATE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2012-11-06 | |
LABELING; Labeling | SUPPL | 2 | AP | 2015-03-16 | STANDARD |
LABELING; Labeling | SUPPL | 3 | AP | 2015-12-21 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 7 |
SUPPL | 2 | Null | 7 |
SUPPL | 3 | Null | 7 |
TE Codes
CDER Filings
WATSON LABS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 202503
[companyName] => WATSON LABS INC
[docInserts] => ["",""]
[products] => [{"drugName":"SILDENAFIL CITRATE","activeIngredients":"SILDENAFIL CITRATE","strength":"EQ 20MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"11\/06\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/202503Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"12\/21\/2015","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/16\/2015","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/21\/2015","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2015-12-21
)
)