Application Sponsors
ANDA 080142 | ANI PHARMS INC | |
Marketing Status
Application Products
001 | TABLET;ORAL | 500MG | 0 | SULFISOXAZOLE | SULFISOXAZOLE |
FDA Submissions
| ORIG | 1 | AP | 1974-03-06 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 58 | AP | 1992-08-14 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 59 | AP | 1993-01-05 | |
LABELING; Labeling | SUPPL | 60 | AP | 1996-04-17 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 61 | AP | 1997-05-30 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 62 | AP | 1998-12-09 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 63 | AP | 1999-08-20 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 64 | AP | 1999-11-05 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 65 | AP | 1999-11-05 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 66 | AP | 1999-11-05 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 67 | AP | 1999-11-05 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 68 | AP | 1999-11-23 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 69 | AP | 2000-01-28 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 71 | AP | 2002-03-12 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 72 | AP | 2002-07-29 | |
Submissions Property Types
SUPPL | 58 | Null | 0 |
SUPPL | 59 | Null | 0 |
SUPPL | 61 | Null | 0 |
SUPPL | 62 | Null | 0 |
SUPPL | 63 | Null | 0 |
SUPPL | 64 | Null | 0 |
SUPPL | 65 | Null | 0 |
SUPPL | 66 | Null | 0 |
SUPPL | 67 | Null | 0 |
SUPPL | 68 | Null | 0 |
SUPPL | 69 | Null | 0 |
SUPPL | 71 | Null | 0 |
SUPPL | 72 | Null | 0 |
CDER Filings
Accessdata Error
cder:Array
(
[0] => Array
(
[ApplNo] => 80142
[companyName] => Accessdata Error
[docInserts] => ["",""]
[products] => []
[labels] =>
[originalApprovals] => []
[supplements] =>
[actionDate] => 0000-00-00
)
)