Application Sponsors
| ANDA 090283 | SUN PHARM INDS LTD | |
Marketing Status
| Over-the-counter | 001 |
| Over-the-counter | 002 |
Application Products
| 001 | TABLET;ORAL | 10MG | 0 | FAMOTIDINE | FAMOTIDINE |
| 002 | TABLET;ORAL | 20MG | 0 | FAMOTIDINE | FAMOTIDINE |
FDA Submissions
| ORIG | 1 | AP | 2009-11-17 | |
| LABELING; Labeling | SUPPL | 2 | AP | 2015-09-02 | |
| LABELING; Labeling | SUPPL | 12 | AP | 2020-05-11 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 2 | Null | 7 |
| SUPPL | 12 | Null | 15 |
CDER Filings
SUN PHARM INDS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 90283
[companyName] => SUN PHARM INDS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"FAMOTIDINE","activeIngredients":"FAMOTIDINE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"},{"drugName":"FAMOTIDINE","activeIngredients":"FAMOTIDINE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"FAMOTIDINE","submission":"FAMOTIDINE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"},{"actionDate":"FAMOTIDINE","submission":"FAMOTIDINE","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)