NDA 212295

COSMO TECHNOLOGIES LTD

FDA Drug Application

Application #212295

Documents

• Label: 2020-07-02
• Letter: 2020-07-06
• Review: 2020-07-31
• Letter: 2020-12-01
• Label: 2020-12-01
• Letter: 2021-04-09
• Label: 2021-04-12
• Federal Register Notice: 2021-10-08
• Label: 2023-01-17

Application Sponsors

NDA 212295

COSMO TECHNOLOGIES LTD

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

20MG

2

BYFAVO

REMIMAZOLAM

FDA Submissions

TYPE 1/4; Type 1 - New Molecular Entity and Type 4 - New Combination	ORIG	1	AP	2020-07-02	STANDARD
LABELING; Labeling	SUPPL	2	AP	2021-04-08	STANDARD
LABELING; Labeling	SUPPL	3	AP	2023-01-13	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	6
SUPPL	3	Null	6

CDER Filings

COSMO TECHNOLOGIES LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212295
            [companyName] => COSMO TECHNOLOGIES LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"BYFAVO","activeIngredients":"REMIMAZOLAM","strength":"20MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"07\/02\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/212295s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"07\/02\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity and Type 4 - New Combination","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/212295s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/212295Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-07-02
        )

)