Documents
Application Sponsors
| NDA 050646 | GLAXOSMITHKLINE | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
| Discontinued | 003 |
| Discontinued | 004 |
Application Products
| 001 | INJECTABLE;INJECTION | 500MG/VIAL | 0 | CEPTAZ | CEFTAZIDIME |
| 002 | INJECTABLE;INJECTION | 1GM/VIAL | 0 | CEPTAZ | CEFTAZIDIME |
| 003 | INJECTABLE;INJECTION | 2GM/VIAL | 0 | CEPTAZ | CEFTAZIDIME |
| 004 | INJECTABLE;INJECTION | 10GM/VIAL | 0 | CEPTAZ | CEFTAZIDIME |
FDA Submissions
| TYPE 2; Type 2 - New Active Ingredient | ORIG | 1 | AP | 1990-09-27 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1992-09-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1991-08-09 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 1994-09-07 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 1994-10-20 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 1996-09-11 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 1996-08-20 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 1998-01-26 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 1996-06-20 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 1996-06-20 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 1996-12-24 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1997-04-03 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1997-11-25 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 2002-03-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 2000-02-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 2002-02-22 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 17 | Null | 0 |
CDER Filings
GLAXOSMITHKLINE
cder:Array
(
[0] => Array
(
[ApplNo] => 50646
[companyName] => GLAXOSMITHKLINE
[docInserts] => ["",""]
[products] => [{"drugName":"CEPTAZ","activeIngredients":"CEFTAZIDIME","strength":"500MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CEPTAZ","activeIngredients":"CEFTAZIDIME","strength":"1GM\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CEPTAZ","activeIngredients":"CEFTAZIDIME","strength":"2GM\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CEPTAZ","activeIngredients":"CEFTAZIDIME","strength":"10GM\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"03\/29\/2002","submission":"SUPPL-14","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/050646s014lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"CEPTAZ","submission":"CEFTAZIDIME","actionType":"500MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CEPTAZ","submission":"CEFTAZIDIME","actionType":"1GM\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CEPTAZ","submission":"CEFTAZIDIME","actionType":"2GM\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CEPTAZ","submission":"CEFTAZIDIME","actionType":"10GM\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 2002-03-29
)
)