Documents
Application Sponsors
ANDA 077421 | LANNETT CO INC | |
Marketing Status
Application Products
001 | SYRUP;ORAL | 1MG/ML | 0 | LORATADINE | LORATADINE |
FDA Submissions
| ORIG | 1 | AP | 2006-06-29 | |
LABELING; Labeling | SUPPL | 4 | AP | 2014-08-12 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 2014-11-07 | |
Submissions Property Types
CDER Filings
LANNETT CO INC
cder:Array
(
[0] => Array
(
[ApplNo] => 77421
[companyName] => LANNETT CO INC
[docInserts] => ["",""]
[products] => [{"drugName":"LORATADINE","activeIngredients":"LORATADINE","strength":"1MG\/ML","dosageForm":"SYRUP;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"LORATADINE","submission":"LORATADINE","actionType":"1MG\/ML","submissionClassification":"SYRUP;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)