Application Sponsors
| ANDA 090595 | MYLAN PHARMS INC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | CAPSULE;ORAL | EQ 20MG BASE | 0 | FLUVASTATIN SODIUM | FLUVASTATIN SODIUM |
| 002 | CAPSULE;ORAL | EQ 40MG BASE | 0 | FLUVASTATIN SODIUM | FLUVASTATIN SODIUM |
FDA Submissions
| ORIG | 1 | AP | 2012-04-11 | |
| LABELING; Labeling | SUPPL | 2 | AP | 2013-03-26 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2020-09-15 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2020-09-25 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 2 | Null | 15 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 7 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
MYLAN PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 90595
[companyName] => MYLAN PHARMS INC
[docInserts] => ["",""]
[products] => [{"drugName":"FLUVASTATIN SODIUM","activeIngredients":"FLUVASTATIN SODIUM","strength":"EQ 20MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FLUVASTATIN SODIUM","activeIngredients":"FLUVASTATIN SODIUM","strength":"EQ 40MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
[labels] =>
[originalApprovals] => [{"actionDate":"FLUVASTATIN SODIUM","submission":"FLUVASTATIN SODIUM","actionType":"EQ 20MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"FLUVASTATIN SODIUM","submission":"FLUVASTATIN SODIUM","actionType":"EQ 40MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)