ANDA 077809

ANI PHARMS INC

FDA Drug Application

Application #077809

Documents

• Other: 2018-05-01

Application Sponsors

ANDA 077809

ANI PHARMS INC

Marketing Status

• Discontinued: 001
• Discontinued: 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	2010-11-30
LABELING; Labeling	SUPPL	2	AP	2012-05-01
LABELING; Labeling	SUPPL	3	AP	2013-11-19	STANDARD
LABELING; Labeling	SUPPL	4	AP	2016-07-26	STANDARD
LABELING; Labeling	SUPPL	5	AP	2017-01-27	STANDARD
LABELING; Labeling	SUPPL	6	AP	2018-10-18	STANDARD
LABELING; Labeling	SUPPL	7	AP	2019-04-24	STANDARD
LABELING; Labeling	SUPPL	8	AP	2019-05-06	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	3	Null	15
SUPPL	4	Null	15
SUPPL	5	Null	7
SUPPL	6	Null	7
SUPPL	7	Null	7
SUPPL	8	Null	15

CDER Filings

ANI PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77809
            [companyName] => ANI PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CIPROFLOXACIN EXTENDED RELEASE","activeIngredients":"CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE","strength":"425.2MG;EQ 574.9MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CIPROFLOXACIN EXTENDED RELEASE","activeIngredients":"CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE","strength":"212.6MG;EQ 287.5MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CIPROFLOXACIN EXTENDED RELEASE","submission":"CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE","actionType":"425.2MG;EQ 574.9MG BASE","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CIPROFLOXACIN EXTENDED RELEASE","submission":"CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE","actionType":"212.6MG;EQ 287.5MG BASE","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)