Application Sponsors
| ANDA 091221 | WATSON LABS INC | |
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
Submissions Property Types
CDER Filings
WATSON LABS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 91221
[companyName] => WATSON LABS INC
[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":"PREGABALIN","submission":"PREGABALIN","actionType":"25MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"},{"actionDate":"PREGABALIN","submission":"PREGABALIN","actionType":"50MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"},{"actionDate":"PREGABALIN","submission":"PREGABALIN","actionType":"75MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"},{"actionDate":"PREGABALIN","submission":"PREGABALIN","actionType":"100MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"},{"actionDate":"PREGABALIN","submission":"PREGABALIN","actionType":"150MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"},{"actionDate":"PREGABALIN","submission":"PREGABALIN","actionType":"200MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"},{"actionDate":"PREGABALIN","submission":"PREGABALIN","actionType":"225MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"},{"actionDate":"PREGABALIN","submission":"PREGABALIN","actionType":"300MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)