Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | EQ 15MG BASE/ML | 0 | ZINACEF IN PLASTIC CONTAINER | CEFUROXIME SODIUM |
| 002 | INJECTABLE;INJECTION | EQ 30MG BASE/ML | 1 | ZINACEF IN PLASTIC CONTAINER | CEFUROXIME SODIUM |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1989-04-28 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 1995-10-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1992-03-30 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 1995-02-06 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 1994-10-27 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 1995-09-29 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 1996-12-23 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 1996-09-11 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 1996-12-23 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2001-07-12 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2001-10-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 2001-04-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 2001-11-09 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2004-05-19 | STANDARD |
| LABELING; Labeling | SUPPL | 21 | AP | 2007-07-30 | STANDARD |
| LABELING; Labeling | SUPPL | 22 | AP | 2014-09-25 | STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 2013-04-29 | STANDARD |
| LABELING; Labeling | SUPPL | 27 | AP | 2021-05-16 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 15 | Null | 9 |
| SUPPL | 22 | Null | 15 |
| SUPPL | 25 | Null | 0 |
| SUPPL | 27 | Null | 7 |
CDER Filings
TELIGENT
cder:Array
(
[0] => Array
(
[ApplNo] => 50643
[companyName] => TELIGENT
[docInserts] => ["",""]
[products] => [{"drugName":"ZINACEF IN PLASTIC CONTAINER","activeIngredients":"CEFUROXIME SODIUM","strength":"EQ 15MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ZINACEF IN PLASTIC CONTAINER","activeIngredients":"CEFUROXIME SODIUM","strength":"EQ 30MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"09\/25\/2014","submission":"SUPPL-22","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/050558s069,050643s022lbl.pdf\"}]","notes":"Please see"},{"actionDate":"07\/30\/2007","submission":"SUPPL-21","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/050558s067,050643s021lbl.pdf\"}]","notes":""},{"actionDate":"05\/19\/2004","submission":"SUPPL-15","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/50558slr057,50643slr015_zinacef_lbl.pdf\"}]","notes":""},{"actionDate":"10\/12\/2001","submission":"SUPPL-11","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/50643s11lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"ZINACEF IN PLASTIC CONTAINER","submission":"CEFUROXIME SODIUM","actionType":"EQ 15MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ZINACEF IN PLASTIC CONTAINER","submission":"CEFUROXIME SODIUM","actionType":"EQ 30MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2014-09-25
)
)