NDA 208744

ACCORD HLTHCARE INC

FDA Drug Application

Application #208744

Documents

• Label: 2018-01-18
• Letter: 2018-01-26
• Review: 2018-10-10
• Letter: 2020-10-23
• Label: 2020-10-23

Application Sponsors

NDA 208744

ACCORD HLTHCARE INC

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	2018-01-18	STANDARD
LABELING; Labeling	SUPPL	3	AP	2020-10-21	STANDARD

Submissions Property Types

ORIG	1	Null	31
SUPPL	3	Null	15

CDER Filings

ACCORD HLTHCARE INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208744
            [companyName] => ACCORD HLTHCARE INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TIGECYCLINE","activeIngredients":"TIGECYCLINE","strength":"50MG\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"01\/18\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/208744s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"01\/18\/2018","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\\\/2018\\\/208744s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/208744Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/208744Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2018-01-18
        )

)