ANDA 091682

SANDOZ

FDA Drug Application

Application #091682

Application Sponsors

ANDA 091682

SANDOZ

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	1,000 UNITS/ML	0	HEPARIN SODIUM	HEPARIN SODIUM
002	INJECTABLE;INJECTION	5,000 UNITS/ML	0	HEPARIN SODIUM	HEPARIN SODIUM

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2011-06-08
LABELING; Labeling	SUPPL	7	AP	2020-06-08	STANDARD
LABELING; Labeling	SUPPL	13	AP	2020-09-29	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	7	Null	15
SUPPL	13	Null	7

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

SANDOZ

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91682
            [companyName] => SANDOZ
            [docInserts] => ["",""]
            [products] => [{"drugName":"HEPARIN SODIUM","activeIngredients":"HEPARIN SODIUM","strength":"1,000 UNITS\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"HEPARIN SODIUM","activeIngredients":"HEPARIN SODIUM","strength":"5,000 UNITS\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HEPARIN SODIUM","submission":"HEPARIN SODIUM","actionType":"1,000 UNITS\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"HEPARIN SODIUM","submission":"HEPARIN SODIUM","actionType":"5,000 UNITS\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)