NDA 205645

FRESENIUS KABI USA

FDA Drug Application

Application #205645

Documents

• Letter: 2016-12-06
• Label: 2016-12-05
• Review: 2017-06-28
• Label: 2017-08-17
• Letter: 2017-08-29
• Letter: 2019-04-05
• Label: 2019-04-05
• Label: 2020-11-16
• Letter: 2020-11-17

Application Sponsors

NDA 205645

FRESENIUS KABI USA

Marketing Status

• Prescription: 001

Application Products

001

POWDER;INTRAVENOUS

50MG/VIAL

0

TIGECYCLINE

TIGECYCLINE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2016-12-01	STANDARD
LABELING; Labeling	SUPPL	3	AP	2019-04-04	STANDARD
LABELING; Labeling	SUPPL	4	AP	2020-11-16	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	3	Null	6
SUPPL	4	Null	6

TE Codes

001	Prescription	AP
002	Prescription	TBD

CDER Filings

FRESENIUS KABI USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205645
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"TIGECYCLINE","activeIngredients":"TIGECYCLINE","strength":"50MG\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"04\/04\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/205645s003lbl.pdf\"}]","notes":""},{"actionDate":"08\/15\/2017","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/205645s001lbl.pdf\"}]","notes":"Please see"},{"actionDate":"12\/01\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/205645lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"12\/01\/2016","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\\\/2016\\\/205645lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/205645Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/205645Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"04\/04\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/205645s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/205645Orig1s003ltr.pdf\"}]","notes":">"},{"actionDate":"08\/15\/2017","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/205645s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/205645Orig1s001ltr.pdf\"}]","notes":"> Please see www.fda.gov\/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs."}]
            [actionDate] => 2019-04-04
        )

)