ANDA 210363

BELOTECA INC

FDA Drug Application

Application #210363

Application Sponsors

ANDA 210363

BELOTECA INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

10MG/2ML (5MG/ML)

0

DIAZEPAM

DIAZEPAM

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-03-18	STANDARD
LABELING; Labeling	SUPPL	4	AP	2021-02-08	STANDARD
LABELING; Labeling	SUPPL	5	AP	2021-06-23	STANDARD
LABELING; Labeling	SUPPL	6	AP	2021-06-23	STANDARD
LABELING; Labeling	SUPPL	7	AP	2022-03-23	STANDARD
LABELING; Labeling	SUPPL	10	AP	2023-01-11	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	4	Null	7
SUPPL	5	Null	15
SUPPL	6	Null	7
SUPPL	7	Null	15
SUPPL	10	Null	7

TE Codes

001

Prescription

AP

CDER Filings

BELOTECA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210363
            [companyName] => BELOTECA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DIAZEPAM","activeIngredients":"DIAZEPAM","strength":"10MG\/2ML (5MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/18\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"11\/06\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-11-06
        )

)