Application Sponsors
| ANDA 071334 | AMNEAL PHARMS NY | |
Marketing Status
Application Products
| 001 | TABLET;ORAL | 400MG | 0 | IBUPROFEN | IBUPROFEN |
FDA Submissions
| ORIG | 1 | AP | 1986-11-25 | |
| 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 | 1987-12-09 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1987-12-14 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1988-04-05 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1988-04-05 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1988-04-05 | |
| LABELING; Labeling | SUPPL | 10 | AP | 1988-03-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1988-07-26 | |
| LABELING; Labeling | SUPPL | 12 | AP | 1988-10-11 | |
| LABELING; Labeling | SUPPL | 13 | AP | 1989-01-19 | |
| LABELING; Labeling | SUPPL | 14 | AP | 1992-01-30 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1998-01-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1997-07-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1999-02-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1999-09-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 2000-09-22 | |
| LABELING; Labeling | SUPPL | 22 | AP | 1999-08-30 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 2000-05-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 2000-05-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 2001-09-25 | |
| LABELING; Labeling | SUPPL | 30 | AP | 2006-05-16 | |
| LABELING; Labeling | SUPPL | 31 | AP | 2006-08-15 | |
| LABELING; Labeling | SUPPL | 35 | AP | 2007-12-26 | |
| LABELING; Labeling | SUPPL | 39 | AP | 2016-05-09 | STANDARD |
| LABELING; Labeling | SUPPL | 40 | AP | 2019-07-22 | STANDARD |
| LABELING; Labeling | SUPPL | 41 | AP | 2021-04-28 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 25 | Null | 0 |
| SUPPL | 39 | Null | 31 |
| SUPPL | 40 | Null | 15 |
| SUPPL | 41 | Null | 15 |
TE Codes
CDER Filings
AMNEAL PHARMS NY
cder:Array
(
[0] => Array
(
[ApplNo] => 71334
[companyName] => AMNEAL PHARMS NY
[docInserts] => ["",""]
[products] => [{"drugName":"IBUPROFEN","activeIngredients":"IBUPROFEN","strength":"400MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"IBUPROFEN","submission":"IBUPROFEN","actionType":"400MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)