ANDA 078990

APOTEX INC

FDA Drug Application

Application #078990

Application Sponsors

ANDA 078990

APOTEX INC

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

	ORIG	1	AP	2018-09-28
LABELING; Labeling	SUPPL	3	AP	2020-03-19	STANDARD
LABELING; Labeling	SUPPL	12	AP	2022-07-28	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	3	Null	7
SUPPL	12	Null	7

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

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78990
            [companyName] => APOTEX INC
            [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":"ENOXAPARIN SODIUM (PRESERVATIVE FREE)","submission":"ENOXAPARIN SODIUM","actionType":"30MG\/0.3ML (100MG\/ML)","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ENOXAPARIN SODIUM (PRESERVATIVE FREE)","submission":"ENOXAPARIN SODIUM","actionType":"40MG\/0.4ML (100MG\/ML)","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ENOXAPARIN SODIUM (PRESERVATIVE FREE)","submission":"ENOXAPARIN SODIUM","actionType":"60MG\/0.6ML (100MG\/ML)","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ENOXAPARIN SODIUM (PRESERVATIVE FREE)","submission":"ENOXAPARIN SODIUM","actionType":"80MG\/0.8ML (100MG\/ML)","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ENOXAPARIN SODIUM (PRESERVATIVE FREE)","submission":"ENOXAPARIN SODIUM","actionType":"100MG\/ML (100MG\/ML)","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ENOXAPARIN SODIUM (PRESERVATIVE FREE)","submission":"ENOXAPARIN SODIUM","actionType":"120MG\/0.8ML (150MG\/ML)","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ENOXAPARIN SODIUM (PRESERVATIVE FREE)","submission":"ENOXAPARIN SODIUM","actionType":"150MG\/ML (150MG\/ML)","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)