Application Sponsors
| ANDA 074045 | LEADING PHARMA LLC | |
Marketing Status
Application Products
| 001 | CAPSULE;ORAL | 20MG | 0 | NIFEDIPINE | NIFEDIPINE |
FDA Submissions
| ORIG | 1 | AP | 1992-04-30 | |
| LABELING; Labeling | SUPPL | 2 | AP | 1996-07-26 | |
| LABELING; Labeling | SUPPL | 3 | AP | 1997-01-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1998-12-31 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 2001-06-19 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 2015-10-02 | UNKNOWN |
| LABELING; Labeling | SUPPL | 8 | AP | 2018-05-21 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 15 |
| SUPPL | 8 | Null | 15 |
TE Codes
CDER Filings
LEADING PHARMA LLC
cder:Array
(
[0] => Array
(
[ApplNo] => 74045
[companyName] => LEADING PHARMA LLC
[docInserts] => ["",""]
[products] => [{"drugName":"NIFEDIPINE","activeIngredients":"NIFEDIPINE","strength":"20MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"NIFEDIPINE","submission":"NIFEDIPINE","actionType":"20MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)