ANDA 209714

HBT LABS INC

FDA Drug Application

Application #209714

Application Sponsors

ANDA 209714

HBT LABS INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRAMUSCULAR

50MG/ML

0

FULVESTRANT

FULVESTRANT

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-11-21	STANDARD
LABELING; Labeling	SUPPL	3	AP	2021-05-28	STANDARD
LABELING; Labeling	SUPPL	4	AP	2021-05-28	STANDARD
LABELING; Labeling	SUPPL	6	AP	2021-05-28	STANDARD

Submissions Property Types

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

TE Codes

001

Prescription

AO

CDER Filings

HBT LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209714
            [companyName] => HBT LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"FULVESTRANT","activeIngredients":"FULVESTRANT","strength":"50MG\/ML","dosageForm":"INJECTABLE;INTRAMUSCULAR","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/21\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-11-21
        )

)