Documents
Application Sponsors
ANDA 075807 | BEXIMCO PHARMS USA | |
Marketing Status
Discontinued | 001 |
Discontinued | 002 |
Application Products
001 | CAPSULE;ORAL | EQ 10MG BASE | 0 | FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE |
002 | CAPSULE;ORAL | EQ 20MG BASE | 0 | FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 2002-01-29 | |
LABELING; Labeling | SUPPL | 4 | AP | 2005-06-07 | |
LABELING; Labeling | SUPPL | 5 | AP | 2005-06-07 | |
LABELING; Labeling | SUPPL | 7 | AP | 2006-01-31 | |
CDER Filings
BEXIMCO PHARMS USA
cder:Array
(
[0] => Array
(
[ApplNo] => 75807
[companyName] => BEXIMCO PHARMS USA
[docInserts] => ["",""]
[products] => [{"drugName":"FLUOXETINE HYDROCHLORIDE","activeIngredients":"FLUOXETINE HYDROCHLORIDE","strength":"EQ 10MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"FLUOXETINE HYDROCHLORIDE","activeIngredients":"FLUOXETINE HYDROCHLORIDE","strength":"EQ 20MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"FLUOXETINE HYDROCHLORIDE","submission":"FLUOXETINE HYDROCHLORIDE","actionType":"EQ 10MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"FLUOXETINE HYDROCHLORIDE","submission":"FLUOXETINE HYDROCHLORIDE","actionType":"EQ 20MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)