Application Sponsors
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Prescription | 004 |
Application Products
001 | TABLET;ORAL | 10MG | 0 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM |
002 | TABLET;ORAL | 20MG | 0 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM |
003 | TABLET;ORAL | 40MG | 0 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM |
004 | TABLET;ORAL | 80MG | 0 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM |
FDA Submissions
| ORIG | 1 | AP | 2008-01-08 | |
LABELING; Labeling | SUPPL | 2 | AP | 2008-06-16 | |
LABELING; Labeling | SUPPL | 15 | AP | 2013-04-18 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 2014-11-03 | UNKNOWN |
LABELING; Labeling | SUPPL | 17 | AP | 2017-07-11 | STANDARD |
LABELING; Labeling | SUPPL | 19 | AP | 2021-02-01 | STANDARD |
LABELING; Labeling | SUPPL | 21 | AP | 2022-10-13 | STANDARD |
Submissions Property Types
SUPPL | 15 | Null | 15 |
SUPPL | 16 | Null | 7 |
SUPPL | 17 | Null | 7 |
SUPPL | 19 | Null | 7 |
SUPPL | 21 | Null | 7 |
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
004 | Prescription | AB |
CDER Filings
LUPIN PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 77917
[companyName] => LUPIN PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"PRAVASTATIN SODIUM","activeIngredients":"PRAVASTATIN SODIUM","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PRAVASTATIN SODIUM","activeIngredients":"PRAVASTATIN SODIUM","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PRAVASTATIN SODIUM","activeIngredients":"PRAVASTATIN SODIUM","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PRAVASTATIN SODIUM","activeIngredients":"PRAVASTATIN SODIUM","strength":"80MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"PRAVASTATIN SODIUM","submission":"PRAVASTATIN SODIUM","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"PRAVASTATIN SODIUM","submission":"PRAVASTATIN SODIUM","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"PRAVASTATIN SODIUM","submission":"PRAVASTATIN SODIUM","actionType":"40MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"PRAVASTATIN SODIUM","submission":"PRAVASTATIN SODIUM","actionType":"80MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)