Application Sponsors
ANDA 071335 | AMNEAL PHARMS NY | |
Marketing Status
Application Products
001 | TABLET;ORAL | 600MG | 0 | IBUPROFEN | IBUPROFEN |
FDA Submissions
| ORIG | 1 | AP | 1986-11-25 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1987-10-08 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1988-01-12 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1988-01-07 | |
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 | |
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 | 2000-04-12 | |
LABELING; Labeling | SUPPL | 22 | AP | 1999-08-30 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 2000-04-12 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 2000-04-12 | |
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 | 41 | AP | 2019-07-22 | STANDARD |
LABELING; Labeling | SUPPL | 42 | AP | 2021-04-28 | STANDARD |
Submissions Property Types
SUPPL | 1 | 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 | 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 | 15 |
SUPPL | 41 | Null | 15 |
SUPPL | 42 | Null | 15 |
TE Codes
CDER Filings
AMNEAL PHARMS NY
cder:Array
(
[0] => Array
(
[ApplNo] => 71335
[companyName] => AMNEAL PHARMS NY
[docInserts] => ["",""]
[products] => [{"drugName":"IBUPROFEN","activeIngredients":"IBUPROFEN","strength":"600MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"IBUPROFEN","submission":"IBUPROFEN","actionType":"600MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)