Application Sponsors
| ANDA 083734 | ANI PHARMS INC | |
Marketing Status
Application Products
| 001 | TABLET;ORAL | 0.5MG;500MG | 0 | PROBENECID AND COLCHICINE | COLCHICINE; PROBENECID |
FDA Submissions
| ORIG | 1 | AP | 1978-06-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 1987-03-03 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 1987-03-03 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 1988-01-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 1988-01-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 1988-01-20 | |
| LABELING; Labeling | SUPPL | 34 | AP | 1990-01-05 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 35 | AP | 1996-02-05 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 36 | AP | 1993-08-03 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 37 | AP | 1997-05-30 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 38 | AP | 1998-12-09 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 39 | AP | 1999-08-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 40 | AP | 2001-07-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 41 | AP | 2001-07-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 42 | AP | 2001-07-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 43 | AP | 2000-01-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 44 | AP | 2001-07-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 46 | AP | 2002-03-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 47 | AP | 2002-07-29 | |
Submissions Property Types
| ORIG | 1 | Null | 0 |
| SUPPL | 29 | Null | 0 |
| SUPPL | 30 | Null | 0 |
| SUPPL | 31 | Null | 0 |
| SUPPL | 32 | Null | 0 |
| SUPPL | 33 | Null | 0 |
| SUPPL | 34 | Null | 0 |
| SUPPL | 35 | Null | 0 |
| SUPPL | 36 | Null | 0 |
| SUPPL | 37 | Null | 0 |
| SUPPL | 38 | Null | 0 |
| SUPPL | 39 | Null | 0 |
| SUPPL | 40 | Null | 0 |
| SUPPL | 41 | Null | 0 |
| SUPPL | 42 | Null | 0 |
| SUPPL | 43 | Null | 0 |
| SUPPL | 44 | Null | 0 |
| SUPPL | 46 | Null | 0 |
| SUPPL | 47 | Null | 0 |
CDER Filings
ANI PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 83734
[companyName] => ANI PHARMS INC
[docInserts] => ["",""]
[products] => [{"drugName":"PROBENECID AND COLCHICINE","activeIngredients":"COLCHICINE; PROBENECID","strength":"0.5MG;500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"PROBENECID AND COLCHICINE","submission":"COLCHICINE; PROBENECID","actionType":"0.5MG;500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)