ANDA 079167

WATSON LABS INC

FDA Drug Application

Application #079167

Documents

• Letter: 2016-05-03
• Label: 2016-05-03

Application Sponsors

ANDA 079167

WATSON LABS INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

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

FDA Submissions

	ORIG	1	AP	2016-04-29
LABELING; Labeling	SUPPL	4	AP	2016-09-06	STANDARD

Submissions Property Types

ORIG	1	Null	1
SUPPL	4	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB

CDER Filings

WATSON LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 79167
            [companyName] => WATSON LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ROSUVASTATIN CALCIUM","activeIngredients":"ROSUVASTATIN CALCIUM","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ROSUVASTATIN CALCIUM","activeIngredients":"ROSUVASTATIN CALCIUM","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ROSUVASTATIN CALCIUM","activeIngredients":"ROSUVASTATIN CALCIUM","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ROSUVASTATIN CALCIUM","activeIngredients":"ROSUVASTATIN CALCIUM","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"04\/29\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/079167Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ROSUVASTATIN CALCIUM","submission":"ROSUVASTATIN CALCIUM","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ROSUVASTATIN CALCIUM","submission":"ROSUVASTATIN CALCIUM","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ROSUVASTATIN CALCIUM","submission":"ROSUVASTATIN CALCIUM","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ROSUVASTATIN CALCIUM","submission":"ROSUVASTATIN CALCIUM","actionType":"40MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2016-04-29
        )

)