Application Sponsors
| ANDA 207211 | MACLEODS PHARMS LTD | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
Application Products
| 001 | CAPSULE;ORAL | EQ 30MG BASE | 0 | OSELTAMIVIR PHOSPHATE | OSELTAMIVIR PHOSPHATE |
| 002 | CAPSULE;ORAL | EQ 45MG BASE | 0 | OSELTAMIVIR PHOSPHATE | OSELTAMIVIR PHOSPHATE |
| 003 | CAPSULE;ORAL | EQ 75MG BASE | 0 | OSELTAMIVIR PHOSPHATE | OSELTAMIVIR PHOSPHATE |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2017-09-14 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2021-03-16 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2021-03-16 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2021-03-16 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 5 | Null | 7 |
| SUPPL | 8 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
CDER Filings
MACLEODS PHARMS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 207211
[companyName] => MACLEODS PHARMS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"OSELTAMIVIR PHOSPHATE","activeIngredients":"OSELTAMIVIR PHOSPHATE","strength":"EQ 30MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OSELTAMIVIR PHOSPHATE","activeIngredients":"OSELTAMIVIR PHOSPHATE","strength":"EQ 45MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OSELTAMIVIR PHOSPHATE","activeIngredients":"OSELTAMIVIR PHOSPHATE","strength":"EQ 75MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"09\/14\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2017-09-14
)
)