Application Sponsors
ANDA 077534 | INVAGEN PHARMS | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Application Products
001 | TABLET;ORAL | EQ 10MG BASE | 0 | CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE |
002 | TABLET;ORAL | EQ 20MG BASE | 0 | CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE |
003 | TABLET;ORAL | EQ 40MG BASE | 0 | CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE |
FDA Submissions
| ORIG | 1 | AP | 2006-10-03 | |
LABELING; Labeling | SUPPL | 2 | AP | 2009-08-21 | |
LABELING; Labeling | SUPPL | 4 | AP | 2012-04-25 | |
LABELING; Labeling | SUPPL | 6 | AP | 2013-04-26 | STANDARD |
LABELING; Labeling | SUPPL | 9 | AP | 2015-03-09 | STANDARD |
LABELING; Labeling | SUPPL | 10 | AP | 2015-03-09 | STANDARD |
LABELING; Labeling | SUPPL | 14 | AP | 2022-11-21 | STANDARD |
LABELING; Labeling | SUPPL | 17 | AP | 2022-11-21 | STANDARD |
LABELING; Labeling | SUPPL | 19 | AP | 2022-11-21 | STANDARD |
LABELING; Labeling | SUPPL | 20 | AP | 2022-11-21 | STANDARD |
Submissions Property Types
SUPPL | 2 | Null | 7 |
SUPPL | 4 | Null | 8 |
SUPPL | 6 | Null | 15 |
SUPPL | 9 | Null | 15 |
SUPPL | 10 | Null | 7 |
SUPPL | 14 | Null | 7 |
SUPPL | 17 | Null | 7 |
SUPPL | 19 | Null | 7 |
SUPPL | 20 | Null | 7 |
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
CDER Filings
INVAGEN PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 77534
[companyName] => INVAGEN PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"CITALOPRAM HYDROBROMIDE","activeIngredients":"CITALOPRAM HYDROBROMIDE","strength":"EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CITALOPRAM HYDROBROMIDE","activeIngredients":"CITALOPRAM HYDROBROMIDE","strength":"EQ 20MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CITALOPRAM HYDROBROMIDE","activeIngredients":"CITALOPRAM HYDROBROMIDE","strength":"EQ 40MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"CITALOPRAM HYDROBROMIDE","submission":"CITALOPRAM HYDROBROMIDE","actionType":"EQ 10MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CITALOPRAM HYDROBROMIDE","submission":"CITALOPRAM HYDROBROMIDE","actionType":"EQ 20MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CITALOPRAM HYDROBROMIDE","submission":"CITALOPRAM HYDROBROMIDE","actionType":"EQ 40MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)