Application Sponsors
| ANDA 063293 | TELIGENT PHARMA INC | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | 0 | CEFOTAN | CEFOTETAN DISODIUM |
| 002 | INJECTABLE;INJECTION | EQ 2GM BASE/VIAL | 0 | CEFOTAN | CEFOTETAN DISODIUM |
FDA Submissions
| ORIG | 1 | AP | 1993-04-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1994-10-11 | |
| LABELING; Labeling | SUPPL | 4 | AP | 1996-08-06 | |
Submissions Property Types
| ORIG | 1 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
CDER Filings
TELIGENT PHARMA INC
cder:Array
(
[0] => Array
(
[ApplNo] => 63293
[companyName] => TELIGENT PHARMA INC
[docInserts] => ["",""]
[products] => [{"drugName":"CEFOTAN","activeIngredients":"CEFOTETAN DISODIUM","strength":"EQ 1GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CEFOTAN","activeIngredients":"CEFOTETAN DISODIUM","strength":"EQ 2GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"CEFOTAN","submission":"CEFOTETAN DISODIUM","actionType":"EQ 1GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CEFOTAN","submission":"CEFOTETAN DISODIUM","actionType":"EQ 2GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)