ANDA 206834

NANJING KING-FRIEND

FDA Drug Application

Application #206834

Application Sponsors

ANDA 206834

NANJING KING-FRIEND

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005
• Prescription: 006
• Prescription: 007

Application Products

001	INJECTABLE;SUBCUTANEOUS	30MG/0.3ML (100MG/ML)	0	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	ENOXAPARIN SODIUM
002	INJECTABLE;SUBCUTANEOUS	40MG/0.4ML (100MG/ML)	0	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	ENOXAPARIN SODIUM
003	INJECTABLE;SUBCUTANEOUS	60MG/0.6ML (100MG/ML)	0	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	ENOXAPARIN SODIUM
004	INJECTABLE;SUBCUTANEOUS	80MG/0.8ML (100MG/ML)	0	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	ENOXAPARIN SODIUM
005	INJECTABLE;SUBCUTANEOUS	100MG/ML (100MG/ML)	0	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	ENOXAPARIN SODIUM
006	INJECTABLE;SUBCUTANEOUS	120MG/0.8ML (150MG/ML)	0	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	ENOXAPARIN SODIUM
007	INJECTABLE;SUBCUTANEOUS	150MG/ML (150MG/ML)	0	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	ENOXAPARIN SODIUM

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-11-29	STANDARD
LABELING; Labeling	SUPPL	9	AP	2022-07-15	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	9	Null	15

TE Codes

001	Prescription	AP
002	Prescription	AP
003	Prescription	AP
004	Prescription	AP
005	Prescription	AP
006	Prescription	AP
007	Prescription	AP

CDER Filings

NANJING KING-FRIEND

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206834
            [companyName] => NANJING KING-FRIEND
            [docInserts] => ["",""]
            [products] => [{"drugName":"ENOXAPARIN SODIUM (PRESERVATIVE FREE)","activeIngredients":"ENOXAPARIN SODIUM","strength":"30MG\/0.3ML (100MG\/ML)","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ENOXAPARIN SODIUM (PRESERVATIVE FREE)","activeIngredients":"ENOXAPARIN SODIUM","strength":"40MG\/0.4ML (100MG\/ML)","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ENOXAPARIN SODIUM (PRESERVATIVE FREE)","activeIngredients":"ENOXAPARIN SODIUM","strength":"60MG\/0.6ML (100MG\/ML)","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ENOXAPARIN SODIUM (PRESERVATIVE FREE)","activeIngredients":"ENOXAPARIN SODIUM","strength":"80MG\/0.8ML (100MG\/ML)","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ENOXAPARIN SODIUM (PRESERVATIVE FREE)","activeIngredients":"ENOXAPARIN SODIUM","strength":"100MG\/ML (100MG\/ML)","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ENOXAPARIN SODIUM (PRESERVATIVE FREE)","activeIngredients":"ENOXAPARIN SODIUM","strength":"120MG\/0.8ML (150MG\/ML)","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ENOXAPARIN SODIUM (PRESERVATIVE FREE)","activeIngredients":"ENOXAPARIN SODIUM","strength":"150MG\/ML (150MG\/ML)","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/29\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-11-29
        )

)