ANDA 211998

BELOTECA INC

FDA Drug Application

Application #211998

Documents

• Letter: 2020-03-23

Application Sponsors

ANDA 211998

BELOTECA INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

50MG/10ML (5MG/ML)

0

DIAZEPAM

DIAZEPAM

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-12-26	STANDARD
LABELING; Labeling	SUPPL	2	AP	2021-02-08	STANDARD
LABELING; Labeling	SUPPL	3	AP	2021-05-21	STANDARD
LABELING; Labeling	SUPPL	4	AP	2021-05-21	STANDARD
LABELING; Labeling	SUPPL	6	AP	2021-08-10	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	7
SUPPL	3	Null	7
SUPPL	4	Null	15
SUPPL	6	Null	15

TE Codes

001

Prescription

AP

CDER Filings

BELOTECA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211998
            [companyName] => BELOTECA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DIAZEPAM","activeIngredients":"DIAZEPAM","strength":"50MG\/10ML (5MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/26\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/211998Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-12-26
        )

)