ANDA 078126

APOTEX INC

FDA Drug Application

Application #078126

Documents

• Letter: 2007-08-07
• Label: 2007-08-07

Application Sponsors

ANDA 078126

APOTEX INC

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

EQ 50MG PHENYTOIN NA/ML

0

FOSPHENYTOIN SODIUM

FOSPHENYTOIN SODIUM

FDA Submissions

	ORIG	1	AP	2007-08-06
LABELING; Labeling	SUPPL	5	AP	2016-06-24	STANDARD
LABELING; Labeling	SUPPL	6	AP	2016-06-24	STANDARD
LABELING; Labeling	SUPPL	7	AP	2016-06-24	STANDARD
LABELING; Labeling	SUPPL	8	AP	2016-06-24	STANDARD
LABELING; Labeling	SUPPL	9	AP	2017-10-31	STANDARD
LABELING; Labeling	SUPPL	10	AP	2017-10-31	STANDARD
LABELING; Labeling	SUPPL	11	AP	2019-10-03	STANDARD
LABELING; Labeling	SUPPL	12	AP	2019-10-03	STANDARD
LABELING; Labeling	SUPPL	13	AP	2022-08-01	STANDARD
LABELING; Labeling	SUPPL	14	AP	2022-08-01	STANDARD
LABELING; Labeling	SUPPL	15	AP	2022-08-01	STANDARD
LABELING; Labeling	SUPPL	16	AP	2022-08-01	STANDARD

Submissions Property Types

SUPPL	5	Null	15
SUPPL	6	Null	15
SUPPL	7	Null	7
SUPPL	8	Null	7
SUPPL	9	Null	7
SUPPL	10	Null	15
SUPPL	11	Null	15
SUPPL	12	Null	15
SUPPL	13	Null	7
SUPPL	14	Null	7
SUPPL	15	Null	15
SUPPL	16	Null	15

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78126
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"FOSPHENYTOIN SODIUM","activeIngredients":"FOSPHENYTOIN SODIUM","strength":"EQ 50MG PHENYTOIN NA\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"08\/06\/2007","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/078126s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"FOSPHENYTOIN SODIUM","submission":"FOSPHENYTOIN SODIUM","actionType":"EQ 50MG PHENYTOIN NA\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2007-08-06
        )

)