Documents
Application Sponsors
| ANDA 090457 | STRIDES PHARMA | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | 150MG | 0 | LAMIVUDINE | LAMIVUDINE |
| 002 | TABLET;ORAL | 300MG | 0 | LAMIVUDINE | LAMIVUDINE |
FDA Submissions
| ORIG | 1 | AP | 2018-04-19 | |
| LABELING; Labeling | SUPPL | 8 | TA | 2016-12-14 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2019-09-26 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2019-09-26 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 42 |
| SUPPL | 8 | Null | 31 |
| SUPPL | 10 | Null | 7 |
| SUPPL | 12 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
STRIDES PHARMA
cder:Array
(
[0] => Array
(
[ApplNo] => 90457
[companyName] => STRIDES PHARMA
[docInserts] => ["",""]
[products] => [{"drugName":"LAMIVUDINE","activeIngredients":"LAMIVUDINE","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LAMIVUDINE","activeIngredients":"LAMIVUDINE","strength":"300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"LAMIVUDINE","submission":"LAMIVUDINE","actionType":"150MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LAMIVUDINE","submission":"LAMIVUDINE","actionType":"300MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)