ANDA 078166

ANCHEN PHARMS

FDA Drug Application

Application #078166

Application Sponsors

ANDA 078166

ANCHEN PHARMS

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	425.2MG;EQ 574.9MG BASE	0	CIPROFLOXACIN EXTENDED RELEASE	CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE
002	TABLET, EXTENDED RELEASE;ORAL	212.6MG;EQ 287.5MG BASE	0	CIPROFLOXACIN EXTENDED RELEASE	CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2007-11-27
LABELING; Labeling	SUPPL	2	AP	2010-03-17
LABELING; Labeling	SUPPL	6	AP	2012-11-14	STANDARD
LABELING; Labeling	SUPPL	8	AP	2013-08-14	STANDARD
LABELING; Labeling	SUPPL	9	AP	2016-07-18	STANDARD
LABELING; Labeling	SUPPL	10	AP	2016-07-18	STANDARD
LABELING; Labeling	SUPPL	11	AP	2016-07-26	STANDARD
LABELING; Labeling	SUPPL	12	AP	2019-04-26	STANDARD
LABELING; Labeling	SUPPL	13	AP	2018-10-18	STANDARD
LABELING; Labeling	SUPPL	14	AP	2019-05-03	STANDARD

Submissions Property Types

SUPPL	2	Null	7
SUPPL	6	Null	15
SUPPL	8	Null	7
SUPPL	9	Null	15
SUPPL	10	Null	15
SUPPL	11	Null	15
SUPPL	12	Null	7
SUPPL	13	Null	7
SUPPL	14	Null	7

TE Codes

001

Prescription

AB

CDER Filings

ANCHEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78166
            [companyName] => ANCHEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"CIPROFLOXACIN EXTENDED RELEASE","activeIngredients":"CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE","strength":"425.2MG;EQ 574.9MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"},{"drugName":"CIPROFLOXACIN EXTENDED RELEASE","activeIngredients":"CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE","strength":"212.6MG;EQ 287.5MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CIPROFLOXACIN EXTENDED RELEASE","submission":"CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE","actionType":"425.2MG;EQ 574.9MG BASE","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CIPROFLOXACIN EXTENDED RELEASE","submission":"CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE","actionType":"212.6MG;EQ 287.5MG BASE","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)