Application Sponsors
| NDA 050637 | PHARMACIA AND UPJOHN | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | ZEFAZONE | CEFMETAZOLE SODIUM |
| 002 | INJECTABLE;INJECTION | EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | ZEFAZONE | CEFMETAZOLE SODIUM |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1989-12-11 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 3 | AP | 2001-09-17 | |
| LABELING; Labeling | SUPPL | 4 | AP | 1993-07-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1993-12-08 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 6 | AP | 2001-09-17 | |
| LABELING; Labeling | SUPPL | 7 | AP | 2001-09-17 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 1993-07-30 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 8 | Null | 0 |
CDER Filings
PHARMACIA AND UPJOHN
cder:Array
(
[0] => Array
(
[ApplNo] => 50637
[companyName] => PHARMACIA AND UPJOHN
[docInserts] => ["",""]
[products] => [{"drugName":"ZEFAZONE","activeIngredients":"CEFMETAZOLE SODIUM","strength":"EQ 1GM BASE\/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"ZEFAZONE","activeIngredients":"CEFMETAZOLE SODIUM","strength":"EQ 2GM BASE\/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"ZEFAZONE","submission":"CEFMETAZOLE SODIUM","actionType":"EQ 1GM BASE\/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"ZEFAZONE","submission":"CEFMETAZOLE SODIUM","actionType":"EQ 2GM BASE\/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)