Documents
Application Sponsors
Marketing Status
| Prescription | 002 |
| Prescription | 003 |
| Prescription | 004 |
Application Products
| 002 | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | EQ 750MG BASE/VIAL | 1 | ZINACEF | CEFUROXIME SODIUM |
| 003 | INJECTABLE;INJECTION | EQ 1.5GM BASE/VIAL | 1 | ZINACEF | CEFUROXIME SODIUM |
| 004 | INJECTABLE;INJECTION | EQ 7.5GM BASE/VIAL | 1 | ZINACEF | CEFUROXIME SODIUM |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1983-10-19 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 1983-12-22 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1984-02-08 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 1984-02-17 | |
| LABELING; Labeling | SUPPL | 6 | AP | 1984-03-05 | |
| LABELING; Labeling | SUPPL | 7 | AP | 1984-04-18 | |
| LABELING; Labeling | SUPPL | 8 | AP | 1984-05-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1984-08-20 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1984-07-27 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1985-04-03 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1985-11-25 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1986-01-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1986-04-17 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1986-05-30 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 1986-10-23 | |
| LABELING; Labeling | SUPPL | 20 | AP | 1988-05-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1987-08-13 | STANDARD |
| LABELING; Labeling | SUPPL | 23 | AP | 1987-08-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1987-09-25 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 1989-03-24 | STANDARD |
| LABELING; Labeling | SUPPL | 26 | AP | 1989-06-30 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 1990-03-22 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 1992-02-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 1992-02-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 1992-11-04 | STANDARD |
| LABELING; Labeling | SUPPL | 31 | AP | 1995-10-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 1992-02-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 1991-08-14 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 35 | AP | 1992-09-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 36 | AP | 1993-02-18 | STANDARD |
| LABELING; Labeling | SUPPL | 37 | AP | 1995-02-06 | STANDARD |
| LABELING; Labeling | SUPPL | 40 | AP | 1992-12-31 | |
| LABELING; Labeling | SUPPL | 41 | AP | 1994-10-27 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 42 | AP | 1993-06-28 | STANDARD |
| LABELING; Labeling | SUPPL | 43 | AP | 1995-09-29 | STANDARD |
| LABELING; Labeling | SUPPL | 44 | AP | 1996-12-23 | STANDARD |
| LABELING; Labeling | SUPPL | 45 | AP | 1996-09-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 46 | AP | 1995-10-31 | STANDARD |
| LABELING; Labeling | SUPPL | 47 | AP | 1996-12-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 48 | AP | 1997-04-03 | STANDARD |
| LABELING; Labeling | SUPPL | 49 | AP | 2001-07-12 | STANDARD |
| LABELING; Labeling | SUPPL | 50 | AP | 2001-10-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 51 | AP | 2001-04-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 52 | AP | 2001-05-05 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 53 | AP | 2001-11-09 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 54 | AP | 2002-10-23 | STANDARD |
| LABELING; Labeling | SUPPL | 57 | AP | 2004-05-19 | STANDARD |
| LABELING; Labeling | SUPPL | 67 | AP | 2007-07-30 | STANDARD |
| LABELING; Labeling | SUPPL | 69 | 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 | 72 | AP | 2013-08-14 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 73 | AP | 2015-03-16 | STANDARD |
| LABELING; Labeling | SUPPL | 75 | AP | 2020-02-11 | STANDARD |
| LABELING; Labeling | SUPPL | 76 | AP | 2021-05-16 | STANDARD |
Submissions Property Types
| SUPPL | 4 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 25 | Null | 0 |
| SUPPL | 27 | Null | 0 |
| SUPPL | 28 | Null | 0 |
| SUPPL | 29 | Null | 0 |
| SUPPL | 30 | Null | 0 |
| SUPPL | 32 | Null | 0 |
| SUPPL | 33 | Null | 0 |
| SUPPL | 35 | Null | 0 |
| SUPPL | 36 | Null | 0 |
| SUPPL | 42 | Null | 0 |
| SUPPL | 46 | Null | 0 |
| SUPPL | 48 | Null | 0 |
| SUPPL | 51 | Null | 0 |
| SUPPL | 52 | Null | 0 |
| SUPPL | 53 | Null | 0 |
| SUPPL | 54 | Null | 0 |
| SUPPL | 57 | Null | 9 |
| SUPPL | 69 | Null | 6 |
| SUPPL | 72 | Null | 0 |
| SUPPL | 73 | Null | 0 |
| SUPPL | 75 | Null | 15 |
| SUPPL | 76 | Null | 15 |
TE Codes
| 002 | Prescription | AB |
| 003 | Prescription | AP |
| 004 | Prescription | AP |
CDER Filings
TELIGENT
cder:Array
(
[0] => Array
(
[ApplNo] => 50558
[companyName] => TELIGENT
[docInserts] => ["",""]
[products] => [{"drugName":"ZINACEF","activeIngredients":"CEFUROXIME SODIUM","strength":"EQ 750MG BASE\/VIAL","dosageForm":"INJECTABLE;INTRAMUSCULAR, INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"ZINACEF","activeIngredients":"CEFUROXIME SODIUM","strength":"EQ 1.5GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"ZINACEF","activeIngredients":"CEFUROXIME SODIUM","strength":"EQ 7.5GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"02\/11\/2020","submission":"SUPPL-75","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/050558s075lbl.pdf\"}]","notes":""},{"actionDate":"09\/25\/2014","submission":"SUPPL-69","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-67","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-57","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-50","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/50558s50lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"ZINACEF","submission":"CEFUROXIME SODIUM","actionType":"EQ 750MG BASE\/VIAL","submissionClassification":"INJECTABLE;INTRAMUSCULAR, INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"ZINACEF","submission":"CEFUROXIME SODIUM","actionType":"EQ 1.5GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"ZINACEF","submission":"CEFUROXIME SODIUM","actionType":"EQ 7.5GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2020-02-11
)
)