Application Sponsors
ANDA 209288 | THEPHARMANETWORK LLC | |
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 | 2018-12-21 | STANDARD |
LABELING; Labeling | SUPPL | 4 | AP | 2023-01-03 | STANDARD |
LABELING; Labeling | SUPPL | 7 | AP | 2023-01-03 | STANDARD |
LABELING; Labeling | SUPPL | 10 | AP | 2023-01-03 | STANDARD |
LABELING; Labeling | SUPPL | 13 | AP | 2023-01-03 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 15 |
SUPPL | 4 | Null | 7 |
SUPPL | 7 | Null | 7 |
SUPPL | 10 | Null | 7 |
SUPPL | 13 | Null | 7 |
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
004 | Prescription | AB |
CDER Filings
THEPHARMANETWORK LLC
cder:Array
(
[0] => Array
(
[ApplNo] => 209288
[companyName] => THEPHARMANETWORK LLC
[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":"12\/21\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"10\/11\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-10-11
)
)