Documents
Application Sponsors
Marketing Status
Application Products
| 001 | SOLUTION;INTRAVENOUS | 600MG/300ML (2MG/ML) | 1 | LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | LINEZOLID |
FDA Submissions
| TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 2015-06-18 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2018-08-22 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2021-07-29 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2021-08-12 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2022-01-18 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2022-02-17 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 6 |
| SUPPL | 2 | Null | 6 |
| SUPPL | 3 | Null | 15 |
| SUPPL | 4 | Null | 6 |
| SUPPL | 5 | Null | 7 |
| SUPPL | 7 | Null | 6 |
CDER Filings
HOSPIRA INC
cder:Array
(
[0] => Array
(
[ApplNo] => 206473
[companyName] => HOSPIRA INC
[docInserts] => ["",""]
[products] => [{"drugName":"LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","activeIngredients":"LINEZOLID","strength":"600MG\/300ML (2MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"08\/22\/2018","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/206473s002lbl.pdf\"}]","notes":""},{"actionDate":"12\/15\/2017","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/206473s001lbl.pdf\"}]","notes":"Please see"},{"actionDate":"06\/18\/2015","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/206473s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"06\/18\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/206473s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/206473Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/206473Orig1s000TOC.cfm\"}]","notes":">"}]
[supplements] => [{"actionDate":"08\/22\/2018","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/206473s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/206473Orig1s002Ltr.pdf\"}]","notes":">"},{"actionDate":"12\/15\/2017","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/206473s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/206473Orig1s001ltr.pdf\"}]","notes":"> Please see www.fda.gov\/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs."}]
[actionDate] => 2018-08-22
)
)