Application Sponsors
| ANDA 071265 | CONTRACT PHARMACAL | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | TABLET;ORAL | 200MG | 0 | IBUPROFEN | IBUPROFEN |
| 002 | TABLET;ORAL | 200MG | 0 | IBUPROFEN | IBUPROFEN |
FDA Submissions
| ORIG | 1 | AP | 1986-10-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1987-03-06 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1987-01-21 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1987-01-21 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1987-01-21 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1987-03-06 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1987-10-02 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1987-12-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1987-12-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1987-12-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1991-08-27 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1991-08-27 | |
| BIOEQUIV; Bioequivalence | SUPPL | 17 | AP | 1990-01-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1993-08-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1994-06-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1996-07-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1996-07-23 | |
| LABELING; Labeling | SUPPL | 23 | AP | 1999-12-01 | |
| LABELING; Labeling | SUPPL | 25 | AP | 2004-09-29 | |
| LABELING; Labeling | SUPPL | 27 | AP | 2006-03-22 | |
| LABELING; Labeling | SUPPL | 46 | AP | 2019-03-21 | STANDARD |
| LABELING; Labeling | SUPPL | 48 | AP | 2019-03-21 | STANDARD |
| LABELING; Labeling | SUPPL | 49 | AP | 2019-03-21 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 46 | Null | 15 |
| SUPPL | 48 | Null | 7 |
| SUPPL | 49 | Null | 15 |
CDER Filings
CONTRACT PHARMACAL
cder:Array
(
[0] => Array
(
[ApplNo] => 71265
[companyName] => CONTRACT PHARMACAL
[docInserts] => ["",""]
[products] => [{"drugName":"IBUPROFEN","activeIngredients":"IBUPROFEN","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"IBUPROFEN","activeIngredients":"IBUPROFEN","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"IBUPROFEN","submission":"IBUPROFEN","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"IBUPROFEN","submission":"IBUPROFEN","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)