ANDA 090218

SANDOZ INC

FDA Drug Application

Application #090218

Documents

• Label: 2015-04-16
• Letter: 2015-04-17
• Review: 2018-02-15
• Review: 2018-02-15

Application Sponsors

ANDA 090218

SANDOZ INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;SUBCUTANEOUS

20MG/ML

0

GLATOPA

GLATIRAMER ACETATE

FDA Submissions

	ORIG	1	AP	2015-04-16
LABELING; Labeling	SUPPL	5	AP	2020-11-09	STANDARD
LABELING; Labeling	SUPPL	8	AP	2020-11-09	STANDARD
LABELING; Labeling	SUPPL	17	AP	2020-11-09	STANDARD
LABELING; Labeling	SUPPL	20	AP	2020-11-09	STANDARD
LABELING; Labeling	SUPPL	21	AP	2020-11-09	STANDARD
LABELING; Labeling	SUPPL	24	AP	2022-09-21	STANDARD
LABELING; Labeling	SUPPL	25	AP	2022-09-21	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	5	Null	15
SUPPL	8	Null	7
SUPPL	17	Null	7
SUPPL	20	Null	15
SUPPL	21	Null	15
SUPPL	24	Null	7
SUPPL	25	Null	15

TE Codes

001

Prescription

AP

CDER Filings

SANDOZ INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90218
            [companyName] => SANDOZ INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"GLATOPA","activeIngredients":"GLATIRAMER ACETATE","strength":"20MG\/ML","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"04\/16\/2015","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/090218Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"GLATOPA","submission":"GLATIRAMER ACETATE","actionType":"20MG\/ML","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2015-04-16
        )

)