Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | CAPSULE;ORAL | 250MG | 0 | CINOBAC | CINOXACIN |
| 002 | CAPSULE;ORAL | 500MG | 0 | CINOBAC | CINOXACIN |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1980-06-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1981-01-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1981-11-03 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 1987-04-13 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1984-05-31 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2007-12-07 | |
| LABELING; Labeling | SUPPL | 8 | AP | 2007-12-07 | |
| LABELING; Labeling | SUPPL | 9 | AP | 1985-10-16 | |
| LABELING; Labeling | SUPPL | 10 | AP | 1985-11-22 | |
| LABELING; Labeling | SUPPL | 11 | AP | 1987-10-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1988-11-25 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 1987-05-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1987-06-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1987-06-18 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2007-12-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1988-12-02 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 1989-08-21 | |
| LABELING; Labeling | SUPPL | 20 | AP | 1992-08-11 | |
| LABELING; Labeling | SUPPL | 21 | AP | 1992-08-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1996-02-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 1996-02-21 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 1998-02-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 1998-08-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 1998-08-04 | STANDARD |
| LABELING; Labeling | SUPPL | 29 | AP | 2002-08-01 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 2000-01-21 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 2000-08-24 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 25 | Null | 0 |
| SUPPL | 26 | Null | 0 |
| SUPPL | 27 | Null | 0 |
| SUPPL | 28 | Null | 0 |
| SUPPL | 30 | Null | 0 |
| SUPPL | 31 | Null | 0 |
CDER Filings
cder:Array
(
[0] => Array
(
[ApplNo] => 18067
[companyName] =>
[docInserts] => ["",""]
[products] => []
[labels] =>
[originalApprovals] => []
[supplements] =>
[actionDate] => 0000-00-00
)
)