Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | FOR SUSPENSION;ORAL | 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | OMNICEF | CEFDINIR |
| 002 | FOR SUSPENSION;ORAL | 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | OMNICEF | CEFDINIR |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1997-12-04 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 2 | AP | 1999-07-14 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 1999-07-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 2001-06-18 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2004-09-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 2004-07-29 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2005-07-19 | STANDARD |
| LABELING; Labeling | SUPPL | 17 | AP | 2007-06-15 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2007-09-14 | STANDARD |
| LABELING; Labeling | SUPPL | 21 | AP | 2008-12-15 | STANDARD |
| LABELING; Labeling | SUPPL | 23 | AP | 2015-11-18 | STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 23 | Null | 6 |
CDER Filings
ABBVIE
cder:Array
(
[0] => Array
(
[ApplNo] => 50749
[companyName] => ABBVIE
[docInserts] => ["",""]
[products] => [{"drugName":"OMNICEF","activeIngredients":"CEFDINIR","strength":"125MG\/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"OMNICEF","activeIngredients":"CEFDINIR","strength":"250MG\/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"11\/18\/2015","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/050739s017,050749s023lbl.pdf\"}]","notes":"Please see"},{"actionDate":"12\/15\/2008","submission":"SUPPL-21","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/050739s015,050749s021lbl.pdf\"}]","notes":""},{"actionDate":"09\/14\/2007","submission":"SUPPL-18","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/050739s014,050749s018lbl.pdf\"}]","notes":""},{"actionDate":"06\/15\/2007","submission":"SUPPL-17","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/050739s013,050749s017lbl.pdf\"}]","notes":""},{"actionDate":"07\/19\/2005","submission":"SUPPL-13","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/050739s010,050749s013lbl.pdf\"}]","notes":""},{"actionDate":"07\/14\/1999","submission":"SUPPL-2","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1999\\\/50749s02lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"OMNICEF","submission":"CEFDINIR","actionType":"125MG\/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"FOR SUSPENSION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"OMNICEF","submission":"CEFDINIR","actionType":"250MG\/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"FOR SUSPENSION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2015-11-18
)
)