ANDA 206921

SANDOZ INC

FDA Drug Application

Application #206921

Documents

• Letter: 2018-02-14

Application Sponsors

ANDA 206921

SANDOZ INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;SUBCUTANEOUS

40MG/ML

0

GLATOPA

GLATIRAMER ACETATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-02-12	STANDARD
LABELING; Labeling	SUPPL	8	AP	2020-11-09	STANDARD
LABELING; Labeling	SUPPL	18	AP	2020-11-09	STANDARD
LABELING; Labeling	SUPPL	20	AP	2020-11-09	STANDARD
LABELING; Labeling	SUPPL	22	AP	2020-11-09	STANDARD
LABELING; Labeling	SUPPL	25	AP	2022-09-21	STANDARD
LABELING; Labeling	SUPPL	26	AP	2022-09-21	STANDARD

Submissions Property Types

ORIG	1	Null	1
SUPPL	8	Null	15
SUPPL	18	Null	7
SUPPL	20	Null	7
SUPPL	22	Null	7
SUPPL	25	Null	7
SUPPL	26	Null	7

TE Codes

001

Prescription

AP

CDER Filings

SANDOZ INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206921
            [companyName] => SANDOZ INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"GLATOPA","activeIngredients":"GLATIRAMER ACETATE","strength":"40MG\/ML","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/12\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/206921Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-02-12
        )

)