Application Sponsors
ANDA 203828 | INDCHEMIE HEALTH | |
Marketing Status
Discontinued | 001 |
Discontinued | 002 |
Discontinued | 003 |
Discontinued | 004 |
Application Products
001 | TABLET;ORAL | EQ 2.5MG BASE | 0 | NEBIVOLOL HYDROCHLORIDE | NEBIVOLOL HYDROCHLORIDE |
002 | TABLET;ORAL | EQ 5MG BASE | 0 | NEBIVOLOL HYDROCHLORIDE | NEBIVOLOL HYDROCHLORIDE |
003 | TABLET;ORAL | EQ 10MG BASE | 0 | NEBIVOLOL HYDROCHLORIDE | NEBIVOLOL HYDROCHLORIDE |
004 | TABLET;ORAL | EQ 20MG BASE | 0 | NEBIVOLOL HYDROCHLORIDE | NEBIVOLOL HYDROCHLORIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2015-07-29 | |
LABELING; Labeling | SUPPL | 3 | AP | 2021-11-19 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
004 | Prescription | AB |
CDER Filings
INDCHEMIE HEALTH
cder:Array
(
[0] => Array
(
[ApplNo] => 203828
[companyName] => INDCHEMIE HEALTH
[docInserts] => ["",""]
[products] => [{"drugName":"NEBIVOLOL HYDROCHLORIDE","activeIngredients":"NEBIVOLOL HYDROCHLORIDE","strength":"EQ 2.5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"NEBIVOLOL HYDROCHLORIDE","activeIngredients":"NEBIVOLOL HYDROCHLORIDE","strength":"EQ 5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"NEBIVOLOL HYDROCHLORIDE","activeIngredients":"NEBIVOLOL HYDROCHLORIDE","strength":"EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"NEBIVOLOL HYDROCHLORIDE","activeIngredients":"NEBIVOLOL HYDROCHLORIDE","strength":"EQ 20MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"07\/29\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2015-07-29
)
)