Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
| Prescription | 004 |
Application Products
| 001 | INJECTABLE;INJECTION | 500MG/VIAL | 1 | FORTAZ | CEFTAZIDIME |
| 002 | INJECTABLE;INJECTION | 1GM/VIAL | 1 | FORTAZ | CEFTAZIDIME |
| 003 | INJECTABLE;INJECTION | 2GM/VIAL | 1 | FORTAZ | CEFTAZIDIME |
| 004 | INJECTABLE;INJECTION | 6GM/VIAL | 1 | FORTAZ | CEFTAZIDIME |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1985-07-19 | PRIORITY |
| LABELING; Labeling | SUPPL | 15 | AP | 1993-04-29 | |
| LABELING; Labeling | SUPPL | 17 | AP | 1993-04-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1990-04-10 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1990-03-22 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1992-02-13 | PRIORITY |
| LABELING; Labeling | SUPPL | 22 | AP | 1994-09-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1992-02-13 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 1991-08-09 | PRIORITY |
| LABELING; Labeling | SUPPL | 27 | AP | 1994-10-20 | |
| LABELING; Labeling | SUPPL | 28 | AP | 1992-12-31 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 1993-02-18 | PRIORITY |
| LABELING; Labeling | SUPPL | 30 | AP | 1996-09-11 | STANDARD |
| LABELING; Labeling | SUPPL | 31 | AP | 1996-08-20 | STANDARD |
| LABELING; Labeling | SUPPL | 32 | AP | 1998-01-26 | STANDARD |
| LABELING; Labeling | SUPPL | 33 | AP | 1996-06-20 | STANDARD |
| LABELING; Labeling | SUPPL | 34 | AP | 1996-06-20 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 35 | AP | 1995-11-03 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 36 | AP | 1996-10-04 | PRIORITY |
| LABELING; Labeling | SUPPL | 37 | AP | 1996-12-24 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 38 | AP | 1997-04-03 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 39 | AP | 1997-11-25 | PRIORITY |
| LABELING; Labeling | SUPPL | 40 | AP | 2002-03-29 | STANDARD |
| LABELING; Labeling | SUPPL | 42 | AP | 2002-03-22 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 43 | AP | 2002-02-22 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 44 | AP | 2002-10-23 | PRIORITY |
| LABELING; Labeling | SUPPL | 46 | AP | 2004-05-19 | STANDARD |
| LABELING; Labeling | SUPPL | 51 | AP | 2007-03-14 | STANDARD |
| LABELING; Labeling | SUPPL | 53 | AP | 2007-07-09 | STANDARD |
| LABELING; Labeling | SUPPL | 55 | AP | 2014-09-24 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 60 | AP | 2015-03-03 | PRIORITY |
| LABELING; Labeling | SUPPL | 61 | AP | 2017-07-28 | STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. |
| LABELING; Labeling | SUPPL | 62 | AP | 2020-02-12 | STANDARD |
| LABELING; Labeling | SUPPL | 64 | AP | 2020-02-11 | STANDARD |
Submissions Property Types
| SUPPL | 18 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 26 | Null | 0 |
| SUPPL | 29 | Null | 0 |
| SUPPL | 35 | Null | 0 |
| SUPPL | 36 | Null | 0 |
| SUPPL | 38 | Null | 0 |
| SUPPL | 39 | Null | 0 |
| SUPPL | 43 | Null | 0 |
| SUPPL | 44 | Null | 0 |
| SUPPL | 46 | Null | 9 |
| SUPPL | 55 | Null | 6 |
| SUPPL | 60 | Null | 0 |
| SUPPL | 61 | Null | 15 |
| SUPPL | 62 | Null | 6 |
| SUPPL | 64 | Null | 6 |
TE Codes
| 001 | Prescription | AP |
| 002 | Prescription | AP |
| 003 | Prescription | AP |
| 004 | Prescription | AP |
CDER Filings
TELIGENT
cder:Array
(
[0] => Array
(
[ApplNo] => 50578
[companyName] => TELIGENT
[docInserts] => ["",""]
[products] => [{"drugName":"FORTAZ","activeIngredients":"CEFTAZIDIME","strength":"500MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"FORTAZ","activeIngredients":"CEFTAZIDIME","strength":"1GM\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"FORTAZ","activeIngredients":"CEFTAZIDIME","strength":"2GM\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"FORTAZ","activeIngredients":"CEFTAZIDIME","strength":"6GM\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"02\/12\/2020","submission":"SUPPL-62","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/050578s062lbl.pdf\"}]","notes":""},{"actionDate":"02\/11\/2020","submission":"SUPPL-64","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/050578s064lbl.pdf\"}]","notes":""},{"actionDate":"07\/28\/2017","submission":"SUPPL-61","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/050578s061,050634s028lbl.pdf\"}]","notes":"Please see"},{"actionDate":"07\/28\/2017","submission":"SUPPL-61","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/050578s061,050634s028lbl.pdf\"}]","notes":"Please see"},{"actionDate":"09\/24\/2014","submission":"SUPPL-55","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/050578s055,050634s023lbledt.pdf\"}]","notes":""},{"actionDate":"09\/24\/2014","submission":"SUPPL-55","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/050578s055,050634s023lbledt.pdf\"}]","notes":""},{"actionDate":"07\/09\/2007","submission":"SUPPL-53","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/050578s053,050634s020lbl.pdf\"}]","notes":""},{"actionDate":"03\/14\/2007","submission":"SUPPL-51","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/050578s051,050634s018lbl.pdf\"}]","notes":""},{"actionDate":"05\/19\/2004","submission":"SUPPL-46","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/50578slr046,50634slr016_fortaz_lbl.pdf\"}]","notes":""},{"actionDate":"03\/29\/2002","submission":"SUPPL-40","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/50578s40lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"FORTAZ","submission":"CEFTAZIDIME","actionType":"500MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"FORTAZ","submission":"CEFTAZIDIME","actionType":"1GM\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"FORTAZ","submission":"CEFTAZIDIME","actionType":"2GM\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"FORTAZ","submission":"CEFTAZIDIME","actionType":"6GM\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2020-02-12
)
)