ANDA 201002

SANDOZ

FDA Drug Application

Application #201002

Application Sponsors

ANDA 201002

SANDOZ

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

10,000 UNITS/ML

0

HEPARIN SODIUM

HEPARIN SODIUM

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2011-06-08
LABELING; Labeling	SUPPL	5	AP	2020-06-08	STANDARD
LABELING; Labeling	SUPPL	9	AP	2020-09-29	STANDARD

Submissions Property Types

ORIG	1	Null	42
SUPPL	5	Null	7
SUPPL	9	Null	15

TE Codes

001

Prescription

AP

CDER Filings

SANDOZ

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201002
            [companyName] => SANDOZ
            [docInserts] => ["",""]
            [products] => [{"drugName":"HEPARIN SODIUM","activeIngredients":"HEPARIN SODIUM","strength":"10,000 UNITS\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/08\/2011","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"06\/08\/2020","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/12\/2012","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-06-08
        )

)