Application Sponsors
| ANDA 072199 | AMNEAL PHARMS NY | |
Marketing Status
Application Products
| 001 | TABLET;ORAL | 200MG | 0 | IBUPROFEN | IBUPROFEN |
FDA Submissions
| ORIG | 1 | AP | 1988-05-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1998-01-20 | |
| LABELING; Labeling | SUPPL | 4 | AP | 1994-11-22 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1997-07-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 2000-08-01 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 2000-08-01 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 2000-08-01 | |
| LABELING; Labeling | SUPPL | 10 | AP | 2000-08-01 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1999-02-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1999-09-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 2000-04-12 | |
| LABELING; Labeling | SUPPL | 15 | AP | 1999-09-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 2000-04-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 2000-04-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 2000-12-06 | |
| LABELING; Labeling | SUPPL | 19 | AP | 2001-03-13 | |
| LABELING; Labeling | SUPPL | 20 | AP | 2001-05-21 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 2001-09-25 | |
| LABELING; Labeling | SUPPL | 22 | AP | 2002-10-22 | |
| LABELING; Labeling | SUPPL | 28 | AP | 2006-10-05 | |
| LABELING; Labeling | SUPPL | 29 | AP | 2006-05-09 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 39 | AP | 2015-08-03 | |
| LABELING; Labeling | SUPPL | 41 | AP | 2015-08-03 | |
Submissions Property Types
| SUPPL | 3 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 39 | Null | 7 |
| SUPPL | 41 | Null | 7 |
CDER Filings
AMNEAL PHARMS NY
cder:Array
(
[0] => Array
(
[ApplNo] => 72199
[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
)
)