ANDA 065342

HIKMA FARMACEUTICA

FDA Drug Application

Application #065342

Documents

• Other Important Information from FDA: 2008-01-17

Application Sponsors

ANDA 065342

HIKMA FARMACEUTICA

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	EQ 250MG BASE/VIAL	0	CEFTRIAXONE	CEFTRIAXONE SODIUM
002	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	EQ 500MG BASE/VIAL	0	CEFTRIAXONE	CEFTRIAXONE SODIUM
003	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	EQ 1GM BASE/VIAL	0	CEFTRIAXONE	CEFTRIAXONE SODIUM
004	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	EQ 2GM BASE/VIAL	0	CEFTRIAXONE	CEFTRIAXONE SODIUM

FDA Submissions

	ORIG	1	AP	2008-01-10
LABELING; Labeling	SUPPL	4	AP	2009-11-20
LABELING; Labeling	SUPPL	7	AP	2010-07-06
LABELING; Labeling	SUPPL	9	AP	2011-08-04
LABELING; Labeling	SUPPL	12	AP	2014-08-29	STANDARD
LABELING; Labeling	SUPPL	14	AP	2020-09-11	STANDARD
LABELING; Labeling	SUPPL	15	AP	2020-09-11	STANDARD
LABELING; Labeling	SUPPL	22	AP	2022-01-13	STANDARD

Submissions Property Types

SUPPL	4	Null	7
SUPPL	7	Null	7
SUPPL	12	Null	15
SUPPL	14	Null	15
SUPPL	15	Null	15
SUPPL	22	Null	7

TE Codes

001	Prescription	AP
002	Prescription	AP
003	Prescription	AP
004	Prescription	AP

CDER Filings

HIKMA FARMACEUTICA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65342
            [companyName] => HIKMA FARMACEUTICA
            [docInserts] => ["",""]
            [products] => [{"drugName":"CEFTRIAXONE","activeIngredients":"CEFTRIAXONE SODIUM","strength":"EQ 250MG BASE\/VIAL","dosageForm":"INJECTABLE;INTRAMUSCULAR, INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CEFTRIAXONE","activeIngredients":"CEFTRIAXONE SODIUM","strength":"EQ 500MG BASE\/VIAL","dosageForm":"INJECTABLE;INTRAMUSCULAR, INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CEFTRIAXONE","activeIngredients":"CEFTRIAXONE SODIUM","strength":"EQ 1GM BASE\/VIAL","dosageForm":"INJECTABLE;INTRAMUSCULAR, INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CEFTRIAXONE","activeIngredients":"CEFTRIAXONE SODIUM","strength":"EQ 2GM BASE\/VIAL","dosageForm":"INJECTABLE;INTRAMUSCULAR, INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CEFTRIAXONE","submission":"CEFTRIAXONE SODIUM","actionType":"EQ 250MG BASE\/VIAL","submissionClassification":"INJECTABLE;INTRAMUSCULAR, INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CEFTRIAXONE","submission":"CEFTRIAXONE SODIUM","actionType":"EQ 500MG BASE\/VIAL","submissionClassification":"INJECTABLE;INTRAMUSCULAR, INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CEFTRIAXONE","submission":"CEFTRIAXONE SODIUM","actionType":"EQ 1GM BASE\/VIAL","submissionClassification":"INJECTABLE;INTRAMUSCULAR, INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CEFTRIAXONE","submission":"CEFTRIAXONE SODIUM","actionType":"EQ 2GM BASE\/VIAL","submissionClassification":"INJECTABLE;INTRAMUSCULAR, INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)