Documents
Application Sponsors
ANDA 075128 | WATSON LABS TEVA | |
Marketing Status
Application Products
001 | TABLET, EXTENDED RELEASE;ORAL | 30MG | 0 | AFEDITAB CR | NIFEDIPINE |
FDA Submissions
| ORIG | 1 | AP | 2000-03-10 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 2002-01-17 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2002-07-17 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 2002-07-17 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 2002-12-30 | |
LABELING; Labeling | SUPPL | 11 | AP | 2005-05-03 | |
Submissions Property Types
SUPPL | 1 | Null | 0 |
SUPPL | 2 | Null | 0 |
SUPPL | 3 | Null | 0 |
SUPPL | 4 | Null | 0 |
SUPPL | 6 | Null | 0 |
CDER Filings
WATSON LABS TEVA
cder:Array
(
[0] => Array
(
[ApplNo] => 75128
[companyName] => WATSON LABS TEVA
[docInserts] => ["",""]
[products] => [{"drugName":"AFEDITAB CR","activeIngredients":"NIFEDIPINE","strength":"30MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"AFEDITAB CR","submission":"NIFEDIPINE","actionType":"30MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)