Application Sponsors
| ANDA 207687 | ACCORD HLTHCARE | |
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 | 2018-03-30 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2019-10-16 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2021-05-17 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2021-05-17 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 4 | Null | 15 |
| SUPPL | 6 | Null | 7 |
| SUPPL | 9 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
| 004 | Prescription | AB |
CDER Filings
ACCORD HLTHCARE
cder:Array
(
[0] => Array
(
[ApplNo] => 207687
[companyName] => ACCORD HLTHCARE
[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":"03\/30\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"10\/16\/2019","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/16\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-10-16
)
)