Application Sponsors
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Prescription | 004 |
Application Products
001 | TABLET;ORAL | EQ 10MG BASE | 0 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM |
002 | TABLET;ORAL | EQ 20MG BASE | 0 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM |
003 | TABLET;ORAL | EQ 40MG BASE | 0 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM |
004 | TABLET;ORAL | EQ 80MG BASE | 0 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2022-11-03 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
004 | Prescription | AB |
CDER Filings
LEPU PHARM
cder:Array
(
[0] => Array
(
[ApplNo] => 216848
[companyName] => LEPU PHARM
[docInserts] => ["",""]
[products] => [{"drugName":"ATORVASTATIN CALCIUM","activeIngredients":"ATORVASTATIN CALCIUM","strength":"EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ATORVASTATIN CALCIUM","activeIngredients":"ATORVASTATIN CALCIUM","strength":"EQ 20MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ATORVASTATIN CALCIUM","activeIngredients":"ATORVASTATIN CALCIUM","strength":"EQ 40MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ATORVASTATIN CALCIUM","activeIngredients":"ATORVASTATIN CALCIUM","strength":"EQ 80MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"11\/03\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2022-11-03
)
)