Other Important Information from FDA | 2008-01-30 |
ANDA 078143 | CELLTRION |
Discontinued | 001 |
Discontinued | 002 |
Discontinued | 003 |
001 | CAPSULE;ORAL | EQ 10MG BASE | 0 | FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE |
002 | CAPSULE;ORAL | EQ 20MG BASE | 0 | FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE |
003 | CAPSULE;ORAL | EQ 40MG BASE | 0 | FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE |
ORIG | 1 | AP | 2008-01-16 | ||
LABELING; Labeling | SUPPL | 2 | AP | 2014-09-26 | STANDARD |
LABELING; Labeling | SUPPL | 3 | AP | 2021-02-09 | STANDARD |
LABELING; Labeling | SUPPL | 4 | AP | 2021-02-09 | STANDARD |
SUPPL | 1 | Null | 8 |
SUPPL | 2 | Null | 7 |
SUPPL | 3 | Null | 7 |
SUPPL | 4 | Null | 15 |
cder:Array ( [0] => Array ( [ApplNo] => 78143 [companyName] => CELLTRION [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"},{"drugName":"FLUOXETINE HYDROCHLORIDE","activeIngredients":"FLUOXETINE HYDROCHLORIDE","strength":"EQ 40MG 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"},{"actionDate":"FLUOXETINE HYDROCHLORIDE","submission":"FLUOXETINE HYDROCHLORIDE","actionType":"EQ 40MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}] [supplements] => [actionDate] => 1969-12-31 ) )