Application Sponsors
ANDA 077849 | LANNETT CO INC | |
Marketing Status
Application Products
001 | SOLUTION;ORAL | EQ 20MG BASE/5ML | 0 | FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 2007-02-09 | |
LABELING; Labeling | SUPPL | 2 | AP | 2008-05-29 | |
LABELING; Labeling | SUPPL | 3 | AP | 2009-03-11 | |
LABELING; Labeling | SUPPL | 4 | AP | 2009-03-11 | |
LABELING; Labeling | SUPPL | 6 | AP | 2014-07-16 | STANDARD |
LABELING; Labeling | SUPPL | 8 | AP | 2014-07-18 | STANDARD |
LABELING; Labeling | SUPPL | 9 | AP | 2016-12-27 | STANDARD |
LABELING; Labeling | SUPPL | 10 | AP | 2017-01-04 | STANDARD |
LABELING; Labeling | SUPPL | 11 | AP | 2021-09-07 | STANDARD |
LABELING; Labeling | SUPPL | 12 | AP | 2021-09-07 | STANDARD |
LABELING; Labeling | SUPPL | 13 | AP | 2021-09-21 | STANDARD |
Submissions Property Types
SUPPL | 6 | Null | 7 |
SUPPL | 8 | Null | 7 |
SUPPL | 9 | Null | 7 |
SUPPL | 10 | Null | 7 |
SUPPL | 11 | Null | 7 |
SUPPL | 12 | Null | 7 |
SUPPL | 13 | Null | 7 |
TE Codes
CDER Filings
LANNETT CO INC
cder:Array
(
[0] => Array
(
[ApplNo] => 77849
[companyName] => LANNETT CO INC
[docInserts] => ["",""]
[products] => [{"drugName":"FLUOXETINE HYDROCHLORIDE","activeIngredients":"FLUOXETINE HYDROCHLORIDE","strength":"EQ 20MG BASE\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"FLUOXETINE HYDROCHLORIDE","submission":"FLUOXETINE HYDROCHLORIDE","actionType":"EQ 20MG BASE\/5ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)