NDA 202172

WATSON LABS INC

FDA Drug Application

Application #202172

Documents

• Letter: 2011-08-08
• Letter: 2016-02-16

Application Sponsors

NDA 202172

WATSON LABS INC

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002
• None (Tentative Approval): 003
• None (Tentative Approval): 004

Application Products

001	TABLET; ORAL	5MG	0	ROSUVASTATIN ZINC	ROSUVASTATIN ZINC
002	TABLET; ORAL	10MG	0	ROSUVASTATIN ZINC	ROSUVASTATIN ZINC
003	TABLET; ORAL	20MG	0	ROSUVASTATIN ZINC	ROSUVASTATIN ZINC
004	TABLET; ORAL	40MG	0	ROSUVASTATIN ZINC	ROSUVASTATIN ZINC

FDA Submissions

TYPE 2; Type 2 - New Active Ingredient

ORIG

1

TA

2016-02-12

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

WATSON LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202172
            [companyName] => WATSON LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ROSUVASTATIN ZINC","activeIngredients":"ROSUVASTATIN ZINC","strength":"5MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"ROSUVASTATIN ZINC","activeIngredients":"ROSUVASTATIN ZINC","strength":"10MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"ROSUVASTATIN ZINC","activeIngredients":"ROSUVASTATIN ZINC","strength":"20MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"ROSUVASTATIN ZINC","activeIngredients":"ROSUVASTATIN ZINC","strength":"40MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/12\/2016","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"Type 2 - New Active Ingredient","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2011\\\/202172s000ltr.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/202172Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-02-12
        )

)