Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Discontinued | 003 |
Application Products
| 001 | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | 1 | CEFOTAN | CEFOTETAN DISODIUM |
| 002 | INJECTABLE;INJECTION | EQ 2GM BASE/VIAL | 1 | CEFOTAN | CEFOTETAN DISODIUM |
| 003 | INJECTABLE;INJECTION | EQ 10GM BASE/VIAL | 0 | CEFOTAN | CEFOTETAN DISODIUM |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1985-12-27 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 2 | AP | 1991-11-25 | |
| LABELING; Labeling | SUPPL | 4 | AP | 1991-11-25 | |
| LABELING; Labeling | SUPPL | 14 | AP | 1991-11-25 | |
| LABELING; Labeling | SUPPL | 16 | AP | 1991-11-25 | |
| LABELING; Labeling | SUPPL | 18 | AP | 1992-05-18 | |
| LABELING; Labeling | SUPPL | 19 | AP | 1992-09-29 | |
| LABELING; Labeling | SUPPL | 20 | AP | 1993-07-30 | STANDARD |
| LABELING; Labeling | SUPPL | 21 | AP | 1995-09-12 | STANDARD |
| LABELING; Labeling | SUPPL | 22 | AP | 1993-07-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1994-09-15 | STANDARD |
| LABELING; Labeling | SUPPL | 25 | AP | 1995-10-20 | STANDARD |
| LABELING; Labeling | SUPPL | 26 | AP | 1999-08-05 | STANDARD |
| LABELING; Labeling | SUPPL | 27 | AP | 2003-03-04 | STANDARD |
| LABELING; Labeling | SUPPL | 29 | AP | 2003-06-20 | STANDARD |
| LABELING; Labeling | SUPPL | 30 | AP | 2004-06-25 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 2015-12-09 | STANDARD |
| LABELING; Labeling | SUPPL | 32 | AP | 2017-03-09 | STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. |
Submissions Property Types
| SUPPL | 23 | Null | 0 |
| SUPPL | 31 | Null | 0 |
| SUPPL | 32 | Null | 6 |
TE Codes
| 001 | Prescription | AP |
| 002 | Prescription | AP |
CDER Filings
TELIGENT
cder:Array
(
[0] => Array
(
[ApplNo] => 50588
[companyName] => TELIGENT
[docInserts] => ["",""]
[products] => [{"drugName":"CEFOTAN","activeIngredients":"CEFOTETAN DISODIUM","strength":"EQ 1GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"CEFOTAN","activeIngredients":"CEFOTETAN DISODIUM","strength":"EQ 2GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"CEFOTAN","activeIngredients":"CEFOTETAN DISODIUM","strength":"EQ 10GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"03\/09\/2017","submission":"SUPPL-32","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/050588s032lbl.pdf\"}]","notes":"Please see"},{"actionDate":"06\/25\/2004","submission":"SUPPL-30","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/50588slr030_cefotan_lbl.pdf\"}]","notes":""},{"actionDate":"06\/20\/2003","submission":"SUPPL-29","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/50588slr029_cefotan_lbl.pdf\"}]","notes":""},{"actionDate":"03\/04\/2003","submission":"SUPPL-27","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/50588slr027_cefotan_lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"CEFOTAN","submission":"CEFOTETAN DISODIUM","actionType":"EQ 1GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"CEFOTAN","submission":"CEFOTETAN DISODIUM","actionType":"EQ 2GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"CEFOTAN","submission":"CEFOTETAN DISODIUM","actionType":"EQ 10GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 2017-03-09
)
)