Application Sponsors
| ANDA 075639 | SUN PHARM INDUSTRIES | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | TABLET;ORAL | 40MG | 0 | FAMOTIDINE | FAMOTIDINE |
| 002 | TABLET;ORAL | 20MG | 0 | FAMOTIDINE | FAMOTIDINE |
FDA Submissions
| ORIG | 1 | AP | 2001-12-12 | |
| LABELING; Labeling | SUPPL | 2 | AP | 2003-05-05 | |
| LABELING; Labeling | SUPPL | 9 | AP | 2021-03-04 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2021-03-04 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2021-03-04 | STANDARD |
Submissions Property Types
| SUPPL | 9 | Null | 7 |
| SUPPL | 10 | Null | 15 |
| SUPPL | 11 | Null | 15 |
CDER Filings
SUN PHARM INDUSTRIES
cder:Array
(
[0] => Array
(
[ApplNo] => 75639
[companyName] => SUN PHARM INDUSTRIES
[docInserts] => ["",""]
[products] => [{"drugName":"FAMOTIDINE","activeIngredients":"FAMOTIDINE","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"FAMOTIDINE","activeIngredients":"FAMOTIDINE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"FAMOTIDINE","submission":"FAMOTIDINE","actionType":"40MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"FAMOTIDINE","submission":"FAMOTIDINE","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)