ANDA 076639

UNIQUE PHARM LABS

FDA Drug Application

Application #076639

Application Sponsors

ANDA 076639

UNIQUE PHARM LABS

Marketing Status

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

Application Products

001	TABLET;ORAL	EQ 250MG BASE	0	CIPROFLOXACIN HYDROCHLORIDE	CIPROFLOXACIN HYDROCHLORIDE
002	TABLET;ORAL	EQ 500MG BASE	0	CIPROFLOXACIN HYDROCHLORIDE	CIPROFLOXACIN HYDROCHLORIDE
003	TABLET;ORAL	EQ 750MG BASE	0	CIPROFLOXACIN HYDROCHLORIDE	CIPROFLOXACIN HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2004-09-10
LABELING; Labeling	SUPPL	2	AP	2010-03-09
LABELING; Labeling	SUPPL	6	AP	2011-05-16
LABELING; Labeling	SUPPL	7	AP	2011-11-28
LABELING; Labeling	SUPPL	8	AP	2012-03-29
LABELING; Labeling	SUPPL	9	AP	2012-07-25	STANDARD
LABELING; Labeling	SUPPL	10	AP	2013-04-22	STANDARD
LABELING; Labeling	SUPPL	11	AP	2015-09-29	STANDARD
LABELING; Labeling	SUPPL	12	AP	2015-09-29	STANDARD
LABELING; Labeling	SUPPL	13	AP	2022-12-19	STANDARD
LABELING; Labeling	SUPPL	14	AP	2022-12-19	STANDARD
LABELING; Labeling	SUPPL	15	AP	2022-12-19	STANDARD
LABELING; Labeling	SUPPL	18	AP	2022-12-19	STANDARD
LABELING; Labeling	SUPPL	19	AP	2022-12-19	STANDARD
LABELING; Labeling	SUPPL	22	AP	2022-12-19	STANDARD
LABELING; Labeling	SUPPL	23	AP	2022-12-19	STANDARD
LABELING; Labeling	SUPPL	27	AP	2022-12-19	STANDARD
LABELING; Labeling	SUPPL	29	AP	2022-12-19	STANDARD
LABELING; Labeling	SUPPL	30	AP	2022-12-19	STANDARD

Submissions Property Types

SUPPL	2	Null	7
SUPPL	7	Null	15
SUPPL	8	Null	15
SUPPL	9	Null	15
SUPPL	10	Null	15
SUPPL	11	Null	7
SUPPL	12	Null	7
SUPPL	13	Null	7
SUPPL	14	Null	7
SUPPL	15	Null	7
SUPPL	18	Null	7
SUPPL	19	Null	7
SUPPL	22	Null	7
SUPPL	23	Null	7
SUPPL	27	Null	7
SUPPL	29	Null	7
SUPPL	30	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

UNIQUE PHARM LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76639
            [companyName] => UNIQUE PHARM LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"CIPROFLOXACIN HYDROCHLORIDE","activeIngredients":"CIPROFLOXACIN HYDROCHLORIDE","strength":"EQ 250MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CIPROFLOXACIN HYDROCHLORIDE","activeIngredients":"CIPROFLOXACIN HYDROCHLORIDE","strength":"EQ 500MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CIPROFLOXACIN HYDROCHLORIDE","activeIngredients":"CIPROFLOXACIN HYDROCHLORIDE","strength":"EQ 750MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CIPROFLOXACIN HYDROCHLORIDE","submission":"CIPROFLOXACIN HYDROCHLORIDE","actionType":"EQ 250MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CIPROFLOXACIN HYDROCHLORIDE","submission":"CIPROFLOXACIN HYDROCHLORIDE","actionType":"EQ 500MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CIPROFLOXACIN HYDROCHLORIDE","submission":"CIPROFLOXACIN HYDROCHLORIDE","actionType":"EQ 750MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)