Application Sponsors
| ANDA 205321 | AUROBINDO PHARMA USA | |
Marketing Status
| None (Tentative Approval) | 001 |
| None (Tentative Approval) | 002 |
| None (Tentative Approval) | 003 |
| None (Tentative Approval) | 004 |
| None (Tentative Approval) | 005 |
| None (Tentative Approval) | 006 |
| None (Tentative Approval) | 007 |
| None (Tentative Approval) | 008 |
Application Products
| 001 | CAPSULE;ORAL | 25MG | 0 | PREGABALIN | PREGABALIN |
| 002 | CAPSULE;ORAL | 50MG | 0 | PREGABALIN | PREGABALIN |
| 003 | CAPSULE;ORAL | 75MG | 0 | PREGABALIN | PREGABALIN |
| 004 | CAPSULE;ORAL | 100MG | 0 | PREGABALIN | PREGABALIN |
| 005 | CAPSULE;ORAL | 150MG | 0 | PREGABALIN | PREGABALIN |
| 006 | CAPSULE;ORAL | 200MG | 0 | PREGABALIN | PREGABALIN |
| 007 | CAPSULE;ORAL | 225MG | 0 | PREGABALIN | PREGABALIN |
| 008 | CAPSULE;ORAL | 300MG | 0 | PREGABALIN | PREGABALIN |
FDA Submissions
| UNKNOWN; | ORIG | 1 | TA | 2018-12-27 | STANDARD |
CDER Filings
AUROBINDO PHARMA USA
cder:Array
(
[0] => Array
(
[ApplNo] => 205321
[companyName] => AUROBINDO PHARMA USA
[docInserts] => ["",""]
[products] => [{"drugName":"PREGABALIN","activeIngredients":"PREGABALIN","strength":"25MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"PREGABALIN","activeIngredients":"PREGABALIN","strength":"50MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"PREGABALIN","activeIngredients":"PREGABALIN","strength":"75MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"PREGABALIN","activeIngredients":"PREGABALIN","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"PREGABALIN","activeIngredients":"PREGABALIN","strength":"150MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"PREGABALIN","activeIngredients":"PREGABALIN","strength":"200MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"PREGABALIN","activeIngredients":"PREGABALIN","strength":"225MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"PREGABALIN","activeIngredients":"PREGABALIN","strength":"300MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"12\/27\/2018","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2018-12-27
)
)