Application Sponsors
ANDA 040228 | ELITE LABS INC | |
Marketing Status
Application Products
001 | CAPSULE;ORAL | 37.5MG | 0 | PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 1997-06-19 | |
LABELING; Labeling | SUPPL | 2 | AP | 1999-05-07 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1999-09-02 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 2002-11-14 | |
LABELING; Labeling | SUPPL | 12 | AP | 2017-05-31 | STANDARD |
Submissions Property Types
SUPPL | 3 | Null | 0 |
SUPPL | 4 | Null | 0 |
SUPPL | 12 | Null | 15 |
TE Codes
CDER Filings
ELITE LABS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 40228
[companyName] => ELITE LABS INC
[docInserts] => ["",""]
[products] => [{"drugName":"PHENTERMINE HYDROCHLORIDE","activeIngredients":"PHENTERMINE HYDROCHLORIDE","strength":"37.5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"PHENTERMINE HYDROCHLORIDE","submission":"PHENTERMINE HYDROCHLORIDE","actionType":"37.5MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)