Ciprofloxacin Extended Release Oral Tablet

Brand(s)
Cipro, Proquin
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Mylan Pharmaceuticals Inc. (2015-03-31)
Oldest Current Product
2005-10-01
License(s)
NDA, ANDA
RxNORM
EXTENDED RELEASE ORAL TABLET\CIPROFLOXACIN
FDAOB
ORAL\TABLET, EXTENDED RELEASE\CIPROFLOXACIN HYDROCHLORIDE
ORAL\TABLET, EXTENDED RELEASE\CIPROFLOXACIN: CIPROFLOXACIN HYDROCHLORIDE
SPL Active
ORAL\TABLET, FILM COATED, EXTENDED RELEASE\CIPROFLOXACIN HYDROCHLORIDE
ORAL\TABLET, FILM COATED, EXTENDED RELEASE\CIPROFLOXACIN: CIPROFLOXACIN HYDROCHLORIDE
SPL Moiety
ORAL\TABLET, FILM COATED, EXTENDED RELEASE\CIPROFLOXACIN

product(s) by strength(s)

24 hr ciprofloxacin 1000 mg extended release oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003781745ANDAMylan Pharmaceuticals Inc.2007-03-22CIPROFLOXACIN, CIPROFLOXACIN HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASEANDA078183b92f9206-325e-4454-9518-4f7464b23f47
2103700108ANDAPar Pharmaceutical, Inc.2011-08-05CIPROFLOXACIN, CIPROFLOXACIN HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASEANDA078166a40db6da-17c6-430c-a247-9900f5863f7c
3551110423ANDADr. Reddy'S Laboratories Ltd2007-10-31CIPROFLOXACIN, CIPROFLOXACIN HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASEANDA0777014ab110e4-7b91-42aa-8052-f24cd79293f0
4620370938ANDAActavis Pharma, Inc.2010-11-30CIPROFLOXACIN, CIPROFLOXACIN HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASEANDA077809c55c5615-e0ea-4f73-9242-bca00c241507

invalid application product(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1504190789CiproNDABayer Healthcare Pharmaceuticals Inc.2012-10-01CIPROFLOXACIN, CIPROFLOXACIN HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASENDA0214734a3cec22-74d0-440a-a9f4-4d5f02e8417a

24 hr ciprofloxacin 500 mg extended release oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003781743ANDAMylan Pharmaceuticals Inc.2007-03-22CIPROFLOXACIN, CIPROFLOXACIN HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASEANDA078183b92f9206-325e-4454-9518-4f7464b23f47
2103700107ANDAPar Pharmaceutical, Inc.2011-08-05CIPROFLOXACIN, CIPROFLOXACIN HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASEANDA078166a40db6da-17c6-430c-a247-9900f5863f7c
3620370942ANDAActavis Pharma, Inc.2010-11-30CIPROFLOXACIN, CIPROFLOXACIN HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASEANDA077417c55c5615-e0ea-4f73-9242-bca00c241507

invalid application product(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1139130001ProquinNDADepomed, Inc.2005-10-01CIPROFLOXACIN HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASENDA021744ff17b6d9-4a76-4cce-af88-aa8316018be6
2504190788CiproNDABayer Healthcare Pharmaceuticals Inc.2012-10-01CIPROFLOXACIN, CIPROFLOXACIN HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASENDA0214734a3cec22-74d0-440a-a9f4-4d5f02e8417a
3551110422ANDADr. Reddy'S Laboratories Ltd2007-03-26CIPROFLOXACIN, CIPROFLOXACIN HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASEANDA0779024ab110e4-7b91-42aa-8052-f24cd79293f0

application(s)

#idtitledeprecatedapplicantapprovedpatentapproved drug
1ANDA077417CIPROFLOXACIN EXTENDED RELEASEACTAVIS LABORATORIES FL INC2010-11-30ANDA077417_001
2ANDA077701CIPROFLOXACIN EXTENDED RELEASEDR REDDYS LABORATORIES LTD2007-03-26ANDA077701_001, ANDA077701_002
3ANDA077809CIPROFLOXACIN EXTENDED RELEASEACTAVIS LABORATORIES FL INC2010-11-30ANDA077809_001
4ANDA078166CIPROFLOXACIN EXTENDED RELEASEANCHEN PHARMACEUTICALS, INC2007-11-27ANDA078166_001, ANDA078166_002
5ANDA078183CIPROFLOXACIN EXTENDED RELEASEMYLAN PHARMACEUTICALS INC2007-03-22ANDA078183_001, ANDA078183_002
6ANDA078712CIPROFLOXACIN EXTENDED RELEASETrueSANDOZ INC2007-12-11ANDA078712_001
7NDA021473CIPRO XRTrueBAYER HEALTHCARE PHARMACEUTICALS INC2002-12-13p7709022, SUBSTANCE
p8187632, SUBSTANCE
NDA021473_001, NDA021473_002
8NDA021744PROQUIN XRTrueDEPOMED INC2005-05-19p6635280, THE TREATMENT OF UNCOMPLICATED URINARY TRACT INFECTIONS, SUBSTANCE
p6488962, SUBSTANCE
p5972389, THE TREATMENT OF UNCOMPLICATED URINARY TRACT INFECTIONS, SUBSTANCE
p6340475, THE TREATMENT OF UNCOMPLICATED URINARY TRACT INFECTIONS, SUBSTANCE
NDA021744_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA077417_001RXCIPROFLOXACIN (212.6MG), CIPROFLOXACIN HYDROCHLORIDE (EQ 287.5MG BASE)ORALTABLET, EXTENDED RELEASEFalseAB2010-11-30CIPROFLOXACIN EXTENDED RELEASE
2ANDA077701_001RXCIPROFLOXACIN HYDROCHLORIDE (EQ 574.9MG BASE), CIPROFLOXACIN (425.2MG)ORALTABLET, EXTENDED RELEASEFalseAB2007-03-26CIPROFLOXACIN EXTENDED RELEASE
3ANDA077701_002discontinuedCIPROFLOXACIN (212.6MG), CIPROFLOXACIN HYDROCHLORIDE (EQ 287.5MG BASE)ORALTABLET, EXTENDED RELEASEFalse2007-10-31CIPROFLOXACIN EXTENDED RELEASE
4ANDA077809_001RXCIPROFLOXACIN (425.2MG), CIPROFLOXACIN HYDROCHLORIDE (EQ 574.9MG BASE)ORALTABLET, EXTENDED RELEASEFalseAB2010-11-30CIPROFLOXACIN EXTENDED RELEASE
5ANDA078166_001RXCIPROFLOXACIN HYDROCHLORIDE (EQ 574.9MG BASE), CIPROFLOXACIN (425.2MG)ORALTABLET, EXTENDED RELEASEFalseAB2007-11-27CIPROFLOXACIN EXTENDED RELEASE
6ANDA078166_002RXCIPROFLOXACIN (212.6MG), CIPROFLOXACIN HYDROCHLORIDE (EQ 287.5MG BASE)ORALTABLET, EXTENDED RELEASEFalseAB2007-11-27CIPROFLOXACIN EXTENDED RELEASE
7ANDA078183_001RXCIPROFLOXACIN HYDROCHLORIDE (EQ 287.5MG BASE), CIPROFLOXACIN (212.6MG)ORALTABLET, EXTENDED RELEASETrueAB2007-03-22CIPROFLOXACIN EXTENDED RELEASE
8ANDA078183_002RXCIPROFLOXACIN (425.2MG), CIPROFLOXACIN HYDROCHLORIDE (EQ 574.9MG BASE)ORALTABLET, EXTENDED RELEASETrueAB2007-03-22CIPROFLOXACIN EXTENDED RELEASE
9ANDA078712_001discontinuedCIPROFLOXACIN (212.6MG), CIPROFLOXACIN HYDROCHLORIDE (EQ 287.5MG BASE)ORALTABLET, EXTENDED RELEASEFalse2007-12-11CIPROFLOXACIN EXTENDED RELEASE
10NDA021473_001discontinuedCIPROFLOXACIN HYDROCHLORIDE (EQ 287.5MG BASE), CIPROFLOXACIN (212.6MG)ORALTABLET, EXTENDED RELEASEFalse2002-12-13CIPRO XR
11NDA021473_002discontinuedCIPROFLOXACIN (425.2MG), CIPROFLOXACIN HYDROCHLORIDE (EQ 574.9MG BASE)ORALTABLET, EXTENDED RELEASEFalse2003-08-28CIPRO XR
12NDA021744_001discontinuedCIPROFLOXACIN HYDROCHLORIDE (EQ 500MG BASE)ORALTABLET, EXTENDED RELEASEFalse2005-05-19PROQUIN XR

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5972389 (view patent)2016-09-19NDA021744
2p6340475 (view patent)2016-09-19NDA021744, NDA021748, NDA022544, NDA202270Metformin / sitagliptin Extended Release Oral Tablet
gabapentin Oral Tablet
Metformin Extended Release Oral Tablet
gabapentin Oral Capsule
3p6488962 (view patent)2020-06-20NDA021744, NDA021748, NDA022544, NDA204031Acetaminophen / Oxycodone Extended Release Oral Tablet
gabapentin Oral Tablet
Metformin Extended Release Oral Tablet
gabapentin Oral Capsule
4p6635280 (view patent)2016-09-19NDA021744, NDA021748, NDA022544, NDA202270Metformin / sitagliptin Extended Release Oral Tablet
gabapentin Oral Tablet
Metformin Extended Release Oral Tablet
gabapentin Oral Capsule
5p7709022 (view patent)2021-06-23NDA021473
6p8187632 (view patent)2021-06-23NDA021473

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
14a3cec22-74d0-440a-a9f4-4d5f02e8417a (view SPL)These highlights do not include all the information needed to use CIPROXR safely and effectively. See full prescribing information for CIPRO XR CIPRO XR (ciprofloxacin) extended-release tablets, for oral use Initial U.S. Approval: 1987prescriptionHuman PrescriptionBayer Healthcare Pharmaceuticals Inc.MANUFACTURE2015-01-315504190788, 504190789
24ab110e4-7b91-42aa-8052-f24cd79293f0 (view SPL)Ciprofloxacin Extended-Release TabletsprescriptionHuman PrescriptionDr. Reddy'S Laboratories Ltdanalysis, manufacture2011-08-305551110422, 551110423
3a40db6da-17c6-430c-a247-9900f5863f7c (view SPL)Ciprofloxacin* Extended-Release TabletsprescriptionHuman PrescriptionPar Pharmaceutical, Inc.ANALYSIS, MANUFACTURE, PACK2014-03-1711103700107, 103700108
4b92f9206-325e-4454-9518-4f7464b23f47 (view SPL)These highlights do not include all the information needed to use ciprofloxacin extended-release tablets safely and effectively. See full prescribing information for ciprofloxacin extended-release tablets. CIPROFLOXACIN extended-release tablets USP, for oral use Initial U.S. Approval: 1987prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2015-03-317003781743, 003781745
5c55c5615-e0ea-4f73-9242-bca00c241507 (view SPL)CIPROFLOXACIN* EXTENDED-RELEASE TABLETS Rx OnlyprescriptionHuman PrescriptionActavis Pharma, Inc.ANALYSIS, MANUFACTURE2012-05-2113620370938, 620370942
6ff17b6d9-4a76-4cce-af88-aa8316018be6 (view SPL)Proquin XR (ciprofloxacin hydrochloride) Extended-Release Tablets, 500 mgprescriptionHuman PrescriptionDepomed, Inc.MANUFACTURE2010-07-062139130001

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII