Application Sponsors
| ANDA 204597 | SCIEGEN PHARMS INC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
Application Products
| 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 |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2015-03-16 | |
| LABELING; Labeling | SUPPL | 3 | AP | 2019-10-29 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2019-10-29 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2019-10-29 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2021-03-01 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 19 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 4 | Null | 7 |
| SUPPL | 5 | Null | 7 |
| SUPPL | 11 | Null | 7 |
TE Codes
| 001 | Prescription | AB1 |
| 002 | Prescription | AB1 |
| 003 | Prescription | AB |
CDER Filings
SCIEGEN PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 204597
[companyName] => SCIEGEN PHARMS INC
[docInserts] => ["",""]
[products] => [{"drugName":"FLUOXETINE HYDROCHLORIDE","activeIngredients":"FLUOXETINE HYDROCHLORIDE","strength":"EQ 10MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FLUOXETINE HYDROCHLORIDE","activeIngredients":"FLUOXETINE HYDROCHLORIDE","strength":"EQ 20MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FLUOXETINE HYDROCHLORIDE","activeIngredients":"FLUOXETINE HYDROCHLORIDE","strength":"EQ 40MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"03\/16\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"10\/29\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/29\/2019","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/29\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-10-29
)
)