Application Sponsors
| ANDA 079021 | MYLAN PHARMS 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 |
Application Products
| 001 | CAPSULE; ORAL | 10MG | 0 | ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE |
| 002 | CAPSULE; ORAL | 18MG | 0 | ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE |
| 003 | CAPSULE; ORAL | 25MG | 0 | ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE |
| 004 | CAPSULE; ORAL | 40MG | 0 | ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE |
| 005 | CAPSULE; ORAL | 60MG | 0 | ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE |
| 006 | CAPSULE; ORAL | 80MG | 0 | ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE |
| 007 | CAPSULE; ORAL | 100MG | 0 | ATOMOXETINE HYDROCHLORIDE | ATOMOXETINE HYDROCHLORIDE |
FDA Submissions
Submissions Property Types
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
| 004 | Prescription | AB |
| 005 | Prescription | AB |
| 006 | Prescription | AB |
| 007 | Prescription | AB |
CDER Filings
MYLAN PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 79021
[companyName] => MYLAN PHARMS INC
[docInserts] => ["",""]
[products] => [{"drugName":"ATOMOXETINE HYDROCHLORIDE","activeIngredients":"ATOMOXETINE HYDROCHLORIDE","strength":"10MG","dosageForm":"CAPSULE; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"ATOMOXETINE HYDROCHLORIDE","activeIngredients":"ATOMOXETINE HYDROCHLORIDE","strength":"18MG","dosageForm":"CAPSULE; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"ATOMOXETINE HYDROCHLORIDE","activeIngredients":"ATOMOXETINE HYDROCHLORIDE","strength":"25MG","dosageForm":"CAPSULE; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"ATOMOXETINE HYDROCHLORIDE","activeIngredients":"ATOMOXETINE HYDROCHLORIDE","strength":"40MG","dosageForm":"CAPSULE; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"ATOMOXETINE HYDROCHLORIDE","activeIngredients":"ATOMOXETINE HYDROCHLORIDE","strength":"60MG","dosageForm":"CAPSULE; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"ATOMOXETINE HYDROCHLORIDE","activeIngredients":"ATOMOXETINE HYDROCHLORIDE","strength":"80MG","dosageForm":"CAPSULE; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"ATOMOXETINE HYDROCHLORIDE","activeIngredients":"ATOMOXETINE HYDROCHLORIDE","strength":"100MG","dosageForm":"CAPSULE; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"ATOMOXETINE HYDROCHLORIDE","submission":"ATOMOXETINE HYDROCHLORIDE","actionType":"10MG","submissionClassification":"CAPSULE; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"},{"actionDate":"ATOMOXETINE HYDROCHLORIDE","submission":"ATOMOXETINE HYDROCHLORIDE","actionType":"18MG","submissionClassification":"CAPSULE; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"},{"actionDate":"ATOMOXETINE HYDROCHLORIDE","submission":"ATOMOXETINE HYDROCHLORIDE","actionType":"25MG","submissionClassification":"CAPSULE; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"},{"actionDate":"ATOMOXETINE HYDROCHLORIDE","submission":"ATOMOXETINE HYDROCHLORIDE","actionType":"40MG","submissionClassification":"CAPSULE; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"},{"actionDate":"ATOMOXETINE HYDROCHLORIDE","submission":"ATOMOXETINE HYDROCHLORIDE","actionType":"60MG","submissionClassification":"CAPSULE; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"},{"actionDate":"ATOMOXETINE HYDROCHLORIDE","submission":"ATOMOXETINE HYDROCHLORIDE","actionType":"80MG","submissionClassification":"CAPSULE; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"},{"actionDate":"ATOMOXETINE HYDROCHLORIDE","submission":"ATOMOXETINE HYDROCHLORIDE","actionType":"100MG","submissionClassification":"CAPSULE; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)