Application Sponsors
ANDA 209236 | AUROBINDO PHARMA LTD | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Application Products
001 | TABLET, EXTENDED RELEASE;ORAL | 500MG | 0 | NIACIN | NIACIN |
002 | TABLET, EXTENDED RELEASE;ORAL | 750MG | 0 | NIACIN | NIACIN |
003 | TABLET, EXTENDED RELEASE;ORAL | 1GM | 0 | NIACIN | NIACIN |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2018-02-01 | STANDARD |
LABELING; Labeling | SUPPL | 3 | AP | 2022-11-29 | STANDARD |
LABELING; Labeling | SUPPL | 5 | AP | 2022-11-29 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 7 |
SUPPL | 3 | Null | 7 |
SUPPL | 5 | Null | 7 |
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
CDER Filings
AUROBINDO PHARMA LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 209236
[companyName] => AUROBINDO PHARMA LTD
[docInserts] => ["",""]
[products] => [{"drugName":"NIACIN","activeIngredients":"NIACIN","strength":"500MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NIACIN","activeIngredients":"NIACIN","strength":"750MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NIACIN","activeIngredients":"NIACIN","strength":"1GM","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"02\/01\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2018-02-01
)
)