ANDA 208600

AMPHASTAR PHARMS INC

FDA Drug Application

Application #208600

Application Sponsors

ANDA 208600

AMPHASTAR PHARMS INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRAVENOUS, SUBCUTANEOUS

300MG/3ML (100MG/ML)

0

ENOXAPARIN SODIUM

ENOXAPARIN SODIUM

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-03-14	STANDARD
LABELING; Labeling	SUPPL	2	AP	2022-11-15	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	7

TE Codes

001

Prescription

AB

CDER Filings

AMPHASTAR PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208600
            [companyName] => AMPHASTAR PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ENOXAPARIN SODIUM","activeIngredients":"ENOXAPARIN SODIUM","strength":"300MG\/3ML (100MG\/ML)","dosageForm":"INJECTABLE;INTRAVENOUS, SUBCUTANEOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/14\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-03-14
        )

)