Application Sponsors
ANDA 071333 | AMNEAL PHARMS NY | |
Marketing Status
Application Products
001 | TABLET;ORAL | 200MG | 0 | IBUPROFEN | IBUPROFEN |
FDA Submissions
| ORIG | 1 | AP | 1987-02-17 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1988-02-17 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1987-10-08 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1988-04-05 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1988-04-05 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1988-04-05 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1988-07-26 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1998-01-20 | |
LABELING; Labeling | SUPPL | 9 | AP | 1994-11-22 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1997-07-24 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 2000-07-25 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 2000-07-25 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 2000-07-25 | |
LABELING; Labeling | SUPPL | 15 | AP | 2000-07-25 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1999-02-11 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1999-09-24 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 2000-04-12 | |
LABELING; Labeling | SUPPL | 20 | AP | 1999-09-13 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 2000-04-12 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 2000-04-12 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 2000-12-04 | |
LABELING; Labeling | SUPPL | 24 | AP | 2001-03-13 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 2001-09-25 | |
LABELING; Labeling | SUPPL | 26 | AP | 2002-10-22 | |
LABELING; Labeling | SUPPL | 32 | AP | 2005-11-16 | |
LABELING; Labeling | SUPPL | 33 | AP | 2006-05-09 | |
LABELING; Labeling | SUPPL | 39 | AP | 2008-08-21 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 44 | AP | 2012-04-25 | |
LABELING; Labeling | SUPPL | 45 | AP | 2011-05-08 | |
Submissions Property Types
SUPPL | 1 | Null | 0 |
SUPPL | 2 | Null | 0 |
SUPPL | 3 | Null | 0 |
SUPPL | 4 | Null | 0 |
SUPPL | 5 | Null | 0 |
SUPPL | 6 | Null | 0 |
SUPPL | 7 | Null | 0 |
SUPPL | 8 | Null | 0 |
SUPPL | 10 | Null | 0 |
SUPPL | 12 | Null | 0 |
SUPPL | 13 | Null | 0 |
SUPPL | 14 | Null | 0 |
SUPPL | 16 | Null | 0 |
SUPPL | 17 | Null | 0 |
SUPPL | 19 | Null | 0 |
SUPPL | 21 | Null | 0 |
SUPPL | 22 | Null | 0 |
SUPPL | 23 | Null | 0 |
SUPPL | 25 | Null | 0 |
SUPPL | 44 | Null | 15 |
CDER Filings
AMNEAL PHARMS NY
cder:Array
(
[0] => Array
(
[ApplNo] => 71333
[companyName] => AMNEAL PHARMS NY
[docInserts] => ["",""]
[products] => [{"drugName":"IBUPROFEN","activeIngredients":"IBUPROFEN","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"IBUPROFEN","submission":"IBUPROFEN","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)