Ciprofloxacin Ophthalmic Solution

Brand(s)
Ciloxan
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Alcon Laboratories, Inc. (2011-07-26)
Oldest Current Product
1990-12-31
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
OPHTHALMIC SOLUTION\CIPROFLOXACIN
FDAOB
OPHTHALMIC\SOLUTION_DROPS\CIPROFLOXACIN HYDROCHLORIDE
SPL Active
OPHTHALMIC\SOLUTION/DROPS\CIPROFLOXACIN HYDROCHLORIDE
OPHTHALMIC\SOLUTION\CIPROFLOXACIN HYDROCHLORIDE
TOPICAL\SOLUTION/DROPS\CIPROFLOXACIN HYDROCHLORIDE
SPL Moiety
OPHTHALMIC\SOLUTION/DROPS\CIPROFLOXACIN
OPHTHALMIC\SOLUTION\CIPROFLOXACIN
TOPICAL\SOLUTION/DROPS\CIPROFLOXACIN

product(s) by strength(s)

ciprofloxacin 3 mg/ml ophthalmic solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000650656CiloxanNDAAlcon Laboratories, Inc.1991-01-15CIPROFLOXACIN HYDROCHLORIDEOPHTHALMICSOLUTIONNDA019992614af481-f9ef-44ac-9cb8-f421660d9cdd

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004047187ANDAHenry Schein Inc.2015-05-13CIPROFLOXACIN HYDROCHLORIDEOPHTHALMICSOLUTION/DROPSANDA0765555f31afd7-d237-44d5-9d07-97ef2c31f5c4
2165710120ANDAPack Pharmaceuticals Llc2008-03-20CIPROFLOXACIN HYDROCHLORIDETOPICALSOLUTION/DROPSANDA077689293852e9-450a-4806-86ca-daba61e59c8e
3165710135ANDAPack Pharmaceuticals Llc2010-09-15CIPROFLOXACIN HYDROCHLORIDEOPHTHALMICSOLUTION/DROPSANDA07756845ff37cf-bb29-4e8b-99b4-881967ef61b3
4174780714ANDAAkorn2009-07-24CIPROFLOXACIN HYDROCHLORIDEOPHTHALMICSOLUTION/DROPSANDA0765553e9a6174-962b-400e-8ca7-4a6c32c60a5d
5242080444ANDABausch & Lomb Incorporated2004-06-09CIPROFLOXACIN HYDROCHLORIDEOPHTHALMICSOLUTION/DROPSANDA0767546d401184-2ff2-4950-820d-ac800469a04f
6400420015ANDAPharmaforce, Inc.2008-01-16CIPROFLOXACIN HYDROCHLORIDEOPHTHALMICSOLUTION/DROPSANDA078598fe8de9e6-3bb1-4395-87af-3ed3aba69db5
7503830282ANDAHi-Tech Pharmacal Co., Inc.2005-01-21CIPROFLOXACIN HYDROCHLORIDEOPHTHALMICSOLUTION/DROPSANDA076673133868ae-a88e-445b-b4df-04d0fcebfbf4
8613140656NDA AUTHORIZED GENERICSandoz Inc2004-05-07CIPROFLOXACIN HYDROCHLORIDEOPHTHALMICSOLUTIONNDA019992ab52b14d-345b-47ff-a832-465caddd3801

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1165900421NDA AUTHORIZED GENERICStat Rx Usa Llc2004-05-07CIPROFLOXACIN HYDROCHLORIDEOPHTHALMICSOLUTION613140656NDA01999211f56251-d913-4986-9dba-c2e4df8a3822
2216950259NDARebel Distributors Corp1990-12-31CIPROFLOXACIN HYDROCHLORIDEOPHTHALMICSOLUTION613140656NDA0199922ef01a91-e73e-46d6-a6f9-d7d6dae91ea2
3422540122ANDARebel Distributors Corp2005-01-21CIPROFLOXACIN HYDROCHLORIDEOPHTHALMICSOLUTION/DROPS503830282ANDA076673637bf5a5-bc69-434d-a199-c2b89837002a
4458650721ANDAMedsource Pharmaceuticals2008-03-20CIPROFLOXACIN HYDROCHLORIDETOPICALSOLUTION/DROPS165710120ANDA0776891fc12db9-6561-509b-e054-00144ff88e88
5458650772ANDAMedsource Pharmaceuticals2005-01-21CIPROFLOXACIN HYDROCHLORIDEOPHTHALMICSOLUTION/DROPS503830282ANDA076673205dc274-ff95-05ac-e054-00144ff88e88
6499990699ANDALake Erie Medical Dba Quality Care Products Llc2005-01-21CIPROFLOXACIN HYDROCHLORIDEOPHTHALMICSOLUTION/DROPS503830282ANDA0766737d9bde0e-03a3-4735-bdd8-8df2bb02b4b4
7504365130ANDAUnit Dose Services2005-01-21CIPROFLOXACIN HYDROCHLORIDEOPHTHALMICSOLUTION/DROPS503830282ANDA07667391db1198-1570-4dc4-897d-8ab207163d69
8521250483ANDARemedyrepack Inc.2013-05-31CIPROFLOXACIN HYDROCHLORIDETOPICALSOLUTION/DROPS165710120ANDA07768977ed008b-4990-4c0a-82cb-42de94cecc38
9521250537ANDARemedyrepack Inc.2013-04-23, 2013-11-18CIPROFLOXACIN HYDROCHLORIDETOPICALSOLUTION/DROPS165710120ANDA0776899270986b-95ae-4f3b-816c-05dabf7f16fd, ad9a6fe4-ea17-4381-8412-162895d996f0
10521250789ANDARemedyrepack Inc.2013-12-17CIPROFLOXACIN HYDROCHLORIDEOPHTHALMICSOLUTION/DROPS503830282ANDA07667398269895-45c1-4154-b472-2d33095217fa
11529590557ANDAH.J. Harkins Company, Inc.2005-01-21CIPROFLOXACIN HYDROCHLORIDEOPHTHALMICSOLUTION/DROPS503830282ANDA0766735bc71138-98ef-49eb-822c-517550b397f8
12548682782CiloxanNDAPhysicians Total Care, Inc.1995-07-10CIPROFLOXACIN HYDROCHLORIDEOPHTHALMICSOLUTION000650656NDA01999291bd0351-f33c-43ca-bd77-7da97969985b
13548685130ANDAPhysicians Total Care, Inc.2004-08-09CIPROFLOXACIN HYDROCHLORIDEOPHTHALMICSOLUTION/DROPS503830282ANDA076673cd6bb11b-3b9d-4d73-a093-d198913c4bff
14581189969ANDAClinical Solutions Wholesale2005-01-21CIPROFLOXACIN HYDROCHLORIDEOPHTHALMICSOLUTION/DROPS503830282ANDA076673506d370a-53ef-4234-87c4-9c1324df3db7
15619190421ANDADirect Rx2014-01-01CIPROFLOXACIN HYDROCHLORIDETOPICALSOLUTION/DROPS165710120ANDA077689f6e09cea-3d9e-48c5-81c3-bbb1bdcdbc98
16631870001ANDAProficient Rx Lp2004-08-09CIPROFLOXACIN HYDROCHLORIDEOPHTHALMICSOLUTION/DROPS503830282ANDA0766734f1d911f-0daf-4975-bfa8-a4c31d8b4ca6
17631870150ANDAProficient Rx Lp2008-03-20CIPROFLOXACIN HYDROCHLORIDETOPICALSOLUTION/DROPS165710120ANDA0776894e2a2c8b-2a56-4b14-ab8c-ca914d0b191a
18631870328ANDAProficient Rx Lp2005-01-21CIPROFLOXACIN HYDROCHLORIDEOPHTHALMICSOLUTION/DROPS503830282ANDA076673e83a6472-3aa5-42d6-8d65-a74688d8feba
19687889391ANDAPreferred Pharmaceuticals, Inc.2014-07-03CIPROFLOXACIN HYDROCHLORIDETOPICALSOLUTION/DROPS165710120ANDA077689b9eae7c0-4a58-44c4-9e10-aef2dd379c5d
20687889944ANDAPreferred Pharmaceuticals, Inc.2012-01-12CIPROFLOXACIN HYDROCHLORIDEOPHTHALMICSOLUTION/DROPS503830282ANDA076673201df228-e84a-4e78-965f-bf83f3db42e6

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA075928CIPROFLOXACIN HYDROCHLORIDETrueAPOTEX INC2004-06-09ANDA075928_001
2ANDA076555CIPROFLOXACIN HYDROCHLORIDEAKORN INC2008-12-11ANDA076555_001
3ANDA076673CIPROFLOXACIN HYDROCHLORIDEWATSON LABORATORIES INC2005-01-21ANDA076673_001
4ANDA076754CIPROFLOXACIN HYDROCHLORIDEIGI LABORATORIES INC2004-06-09ANDA076754_001
5ANDA077568CIPROFLOXACIN HYDROCHLORIDEFDC LTD2008-06-30ANDA077568_001
6ANDA077689CIPROFLOXACIN HYDROCHLORIDERISING PHARMACEUTICALS INC2006-12-13ANDA077689_001
7ANDA078598CIPROFLOXACIN HYDROCHLORIDEPHARMAFORCE INC2008-01-16ANDA078598_001
8NDA019992CILOXANALCON PHARMACEUTICALS LTD1990-12-31NDA019992_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA075928_001discontinuedCIPROFLOXACIN HYDROCHLORIDE (EQ 0.3% BASE)OPHTHALMICSOLUTION/DROPSFalse2004-06-09CIPROFLOXACIN HYDROCHLORIDE
2ANDA076555_001RXCIPROFLOXACIN HYDROCHLORIDE (EQ 0.3% BASE)OPHTHALMICSOLUTION/DROPSFalseAT2008-12-11CIPROFLOXACIN HYDROCHLORIDE
3ANDA076673_001RXCIPROFLOXACIN HYDROCHLORIDE (EQ 0.3% BASE)OPHTHALMICSOLUTION/DROPSFalseAT2005-01-21CIPROFLOXACIN HYDROCHLORIDE
4ANDA076754_001RXCIPROFLOXACIN HYDROCHLORIDE (EQ 0.3% BASE)OPHTHALMICSOLUTION/DROPSFalseAT2004-06-09CIPROFLOXACIN HYDROCHLORIDE
5ANDA077568_001RXCIPROFLOXACIN HYDROCHLORIDE (EQ 0.3% BASE)OPHTHALMICSOLUTION/DROPSFalseAT2008-06-30CIPROFLOXACIN HYDROCHLORIDE
6ANDA077689_001RXCIPROFLOXACIN HYDROCHLORIDE (EQ 0.3% BASE)OPHTHALMICSOLUTION/DROPSFalseAT2006-12-13CIPROFLOXACIN HYDROCHLORIDE
7ANDA078598_001RXCIPROFLOXACIN HYDROCHLORIDE (EQ 0.3% BASE)OPHTHALMICSOLUTION/DROPSFalseAT2008-01-16CIPROFLOXACIN HYDROCHLORIDE
8NDA019992_001RXCIPROFLOXACIN HYDROCHLORIDE (EQ 0.3% BASE)OPHTHALMICSOLUTION/DROPSTrueAT1990-12-31CILOXAN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
111f56251-d913-4986-9dba-c2e4df8a3822 (view SPL)Ciprofloxacin Hydrochloride Ophthalmic Solution 0.3% as baseSterileprescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2012-10-111165900421
2133868ae-a88e-445b-b4df-04d0fcebfbf4 (view SPL)Ciprofloxacin Ophthalmic SolutionprescriptionHuman PrescriptionHi-Tech Pharmacal Co., Inc.2012-02-293503830282
31fc12db9-6561-509b-e054-00144ff88e88 (view SPL)prescriptionHuman PrescriptionMedsource Pharmaceuticalsrelabel2015-09-141458650721
4201df228-e84a-4e78-965f-bf83f3db42e6 (view SPL)Ciprofloxacin Ophthalmic SolutionprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.RELABEL2014-08-273687889944
5205dc274-ff95-05ac-e054-00144ff88e88 (view SPL)Ciprofloxacin Ophthalmic SolutionprescriptionHuman PrescriptionMedsource Pharmaceuticalsrelabel2015-09-221458650772
6293852e9-450a-4806-86ca-daba61e59c8e (view SPL)prescriptionHuman PrescriptionPack Pharmaceuticals LlcMANUFACTURE2012-02-031165710120
72ef01a91-e73e-46d6-a6f9-d7d6dae91ea2 (view SPL)CIPROFLOXACIN HYDROCHLORIDE OPHTHALMIC SOLUTION0.3% as baseSterileprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-09-231216950259
83e9a6174-962b-400e-8ca7-4a6c32c60a5d (view SPL)CIPROFLOXACIN OPHTHALMIC SOLUTION, USP 0.3% as base SterileprescriptionHuman PrescriptionAkornANALYSIS, MANUFACTURE, REPACK2011-10-114174780714
945ff37cf-bb29-4e8b-99b4-881967ef61b3 (view SPL)Ciprofloxacin Ophthalmic SolutionUSP0.3% as baseprescriptionHuman PrescriptionPack Pharmaceuticals Llcanalysis, manufacture2010-07-271165710135
104e2a2c8b-2a56-4b14-ab8c-ca914d0b191a (view SPL)prescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2014-09-091631870150
114f1d911f-0daf-4975-bfa8-a4c31d8b4ca6 (view SPL)prescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2014-11-011631870001
12506d370a-53ef-4234-87c4-9c1324df3db7 (view SPL)Ciprofloxacin Ophthalmic SolutionprescriptionHuman PrescriptionClinical Solutions WholesaleRELABEL2013-11-141581189969
135bc71138-98ef-49eb-822c-517550b397f8 (view SPL)Ciprofloxacin Ophthalmic SolutionprescriptionHuman PrescriptionH.J. Harkins Company, Inc.manufacture2011-12-212529590557
145f31afd7-d237-44d5-9d07-97ef2c31f5c4 (view SPL)CIPROFLOXACIN OPHTHALMICSOLUTION, USP0.3% as baseSterileprescriptionHuman PrescriptionHenry Schein Inc.2015-05-132004047187
15614af481-f9ef-44ac-9cb8-f421660d9cdd (view SPL)Ciloxan (ciprofloxacin HCl ophthalmic solution) 0.3% as baseSterileprescriptionHuman PrescriptionAlcon Laboratories, Inc.MANUFACTURE2011-07-262000650656
16637bf5a5-bc69-434d-a199-c2b89837002a (view SPL)Ciprofloxacin Ophthalmic SolutionprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2012-01-101422540122
176d401184-2ff2-4950-820d-ac800469a04f (view SPL)Ciprofloxacin Ophthalmic Solution USP, 0.3% as baseprescriptionHuman PrescriptionBausch & Lomb IncorporatedMANUFACTURE2011-06-284242080444
1877ed008b-4990-4c0a-82cb-42de94cecc38 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2013-05-311521250483
197d9bde0e-03a3-4735-bdd8-8df2bb02b4b4 (view SPL)Ciprofloxacin Ophthalmic SolutionprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrelabel2013-06-281499990699
2091bd0351-f33c-43ca-bd77-7da97969985b (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2010-12-131548682782
2191db1198-1570-4dc4-897d-8ab207163d69 (view SPL)Ciprofloxacin Ophthalmic SolutionprescriptionHuman PrescriptionUnit Dose ServicesREPACK2012-02-292504365130
229270986b-95ae-4f3b-816c-05dabf7f16fd (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2013-11-181521250537
2398269895-45c1-4154-b472-2d33095217fa (view SPL)Ciprofloxacin Ophthalmic SolutionprescriptionHuman PrescriptionRemedyrepack Inc.2013-12-171521250789
24ab52b14d-345b-47ff-a832-465caddd3801 (view SPL)Ciprofloxacin Hydrochloride Ophthalmic Solution 0.3% as baseSterileprescriptionHuman PrescriptionSandoz IncMANUFACTURE2011-07-232613140656
25ad9a6fe4-ea17-4381-8412-162895d996f0 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2013-04-231521250537
26b9eae7c0-4a58-44c4-9e10-aef2dd379c5d (view SPL)prescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.RELABEL2014-07-081687889391
27cd6bb11b-3b9d-4d73-a093-d198913c4bff (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2010-12-131548685130
28e83a6472-3aa5-42d6-8d65-a74688d8feba (view SPL)Ciprofloxacin Ophthalmic SolutionprescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2015-02-011631870328
29f6e09cea-3d9e-48c5-81c3-bbb1bdcdbc98 (view SPL)CIPROFLOXACINprescriptionHuman PrescriptionDirect Rxrelabel2014-07-171619190421
30fe8de9e6-3bb1-4395-87af-3ed3aba69db5 (view SPL)CIPROFLOXACIN OPHTHALMIC SOLUTION, USP 0.3% AS BASEprescriptionHuman PrescriptionPharmaforce, Inc.ANALYSIS, MANUFACTURE2014-03-052400420015

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