ANDA 205935

SANDOZ INC

FDA Drug Application

Application #205935

Application Sponsors

ANDA 205935

SANDOZ INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRAMUSCULAR

50MG/ML

0

FULVESTRANT

FULVESTRANT

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-05-14	STANDARD
LABELING; Labeling	SUPPL	2	AP	2021-03-19	STANDARD
LABELING; Labeling	SUPPL	4	AP	2021-03-19	STANDARD
LABELING; Labeling	SUPPL	5	AP	2021-03-19	STANDARD
LABELING; Labeling	SUPPL	6	AP	2021-03-19	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15
SUPPL	4	Null	7
SUPPL	5	Null	15
SUPPL	6	Null	15

TE Codes

001

Prescription

AO

CDER Filings

SANDOZ INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205935
            [companyName] => SANDOZ INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"FULVESTRANT","activeIngredients":"FULVESTRANT","strength":"50MG\/ML","dosageForm":"INJECTABLE;INTRAMUSCULAR","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/14\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-05-14
        )

)