Documents
Application Sponsors
Marketing Status
Application Products
001 | INJECTABLE;INJECTION | 10MG/ML | 0 | FAMOTIDINE | FAMOTIDINE |
FDA Submissions
| ORIG | 1 | AP | 2001-04-16 | |
LABELING; Labeling | SUPPL | 6 | AP | 2008-06-03 | |
LABELING; Labeling | SUPPL | 15 | AP | 2020-09-09 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
ATHENEX INC
cder:Array
(
[0] => Array
(
[ApplNo] => 75651
[companyName] => ATHENEX INC
[docInserts] => ["",""]
[products] => [{"drugName":"FAMOTIDINE","activeIngredients":"FAMOTIDINE","strength":"10MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"FAMOTIDINE","submission":"FAMOTIDINE","actionType":"10MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)