Documents
Application Sponsors
| ANDA 075049 | APNAR PHARMA LP | |
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
| ORIG | 1 | AP | 2001-08-02 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 2002-01-29 | |
| LABELING; Labeling | SUPPL | 3 | AP | 2002-01-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 2002-01-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 2002-01-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 2002-01-29 | |
| LABELING; Labeling | SUPPL | 8 | AP | 2002-01-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 2002-01-29 | |
| LABELING; Labeling | SUPPL | 10 | AP | 2002-01-29 | |
| LABELING; Labeling | SUPPL | 11 | AP | 2003-11-19 | |
| LABELING; Labeling | SUPPL | 12 | AP | 2004-09-13 | |
| LABELING; Labeling | SUPPL | 13 | AP | 2004-09-13 | |
| LABELING; Labeling | SUPPL | 14 | AP | 2005-06-09 | |
| LABELING; Labeling | SUPPL | 17 | AP | 2005-06-09 | |
| LABELING; Labeling | SUPPL | 19 | AP | 2006-01-31 | |
| LABELING; Labeling | SUPPL | 20 | AP | 2006-11-06 | |
| LABELING; Labeling | SUPPL | 21 | AP | 2007-11-07 | |
| LABELING; Labeling | SUPPL | 23 | AP | 2007-11-07 | |
| LABELING; Labeling | SUPPL | 27 | AP | 2008-10-21 | |
| LABELING; Labeling | SUPPL | 30 | AP | 2009-08-21 | |
| LABELING; Labeling | SUPPL | 32 | AP | 2010-08-09 | |
| LABELING; Labeling | SUPPL | 35 | AP | 2020-09-28 | STANDARD |
| LABELING; Labeling | SUPPL | 36 | AP | 2020-09-28 | STANDARD |
| LABELING; Labeling | SUPPL | 39 | AP | 2020-09-28 | STANDARD |
| LABELING; Labeling | SUPPL | 40 | AP | 2020-09-28 | STANDARD |
| LABELING; Labeling | SUPPL | 42 | AP | 2020-09-28 | STANDARD |
Submissions Property Types
| SUPPL | 2 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 30 | Null | 7 |
| SUPPL | 35 | Null | 15 |
| SUPPL | 36 | Null | 7 |
| SUPPL | 39 | Null | 15 |
| SUPPL | 40 | Null | 15 |
| SUPPL | 42 | Null | 15 |
TE Codes
| 001 | Prescription | AB1 |
| 002 | Prescription | AB1 |
| 003 | Prescription | AB |
CDER Filings
APNAR PHARMA LP
cder:Array
(
[0] => Array
(
[ApplNo] => 75049
[companyName] => APNAR PHARMA LP
[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] => [{"actionDate":"08\/02\/2001","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/anda\\\/2001\\\/75049_FLUOXETINE_Prntlbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"FLUOXETINE HYDROCHLORIDE","submission":"FLUOXETINE HYDROCHLORIDE","actionType":"EQ 10MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"FLUOXETINE HYDROCHLORIDE","submission":"FLUOXETINE HYDROCHLORIDE","actionType":"EQ 20MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"FLUOXETINE HYDROCHLORIDE","submission":"FLUOXETINE HYDROCHLORIDE","actionType":"EQ 40MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 2001-08-02
)
)