Levofloxacin Ophthalmic Solution

Brand(s)
Iquix, Quixin
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Pack Pharmaceuticals Llc (2011-05-04)
Oldest Current Product
2000-10-01
License(s)
NDA, ANDA
RxNORM
OPHTHALMIC SOLUTION\LEVOFLOXACIN
FDAOB
OPHTHALMIC\SOLUTION_DROPS\LEVOFLOXACIN
SPL Active
OPHTHALMIC\SOLUTION/DROPS\LEVOFLOXACIN
OPHTHALMIC\SOLUTION\LEVOFLOXACIN
TOPICAL\SOLUTION/DROPS\LEVOFLOXACIN
SPL Moiety
OPHTHALMIC\SOLUTION/DROPS\LEVOFLOXACIN ANHYDROUS
OPHTHALMIC\SOLUTION\LEVOFLOXACIN
TOPICAL\SOLUTION/DROPS\LEVOFLOXACIN

product(s) by strength(s)

invalid application product(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1686690145IquixNDAVistakon Pharmaceuticals Llc2004-06-01LEVOFLOXACINOPHTHALMICSOLUTIONNDA021571067ea8ec-99a3-4a0b-9116-4ffd6160b24b

levofloxacin 5 mg/ml ophthalmic solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1165710150ANDAPack Pharmaceuticals Llc2010-12-20LEVOFLOXACINTOPICALSOLUTION/DROPSANDA077700f79d2ae4-ccfb-49ca-bf0e-e505f3477d30
2174780106ANDAAkorn2011-03-01LEVOFLOXACINOPHTHALMICSOLUTIONANDA0902686987500a-2feb-48a9-9d29-89693333a801
3503830283ANDAHi-Tech Pharmacal Co., Inc.2011-02-10LEVOFLOXACINOPHTHALMICSOLUTION/DROPSANDA0768262bc7f52d-05a5-4dc7-98a8-9412a2c53ea2

invalid application product(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1686690135QuixinNDAVistakon Pharmaceuticals Llc2000-10-01LEVOFLOXACINOPHTHALMICSOLUTIONNDA02119909b3a912-97f9-45ae-a162-9f45c860dc22

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA076826LEVOFLOXACINWATSON LABORATORIES INC2011-02-10ANDA076826_001
2ANDA077700LEVOFLOXACINNEXUS PHARMACEUTICALS INC2010-12-20ANDA077700_001
3ANDA078282LEVOFLOXACINTrueAPOTEX INC2010-12-20ANDA078282_001
4ANDA090268LEVOFLOXACINAKORN INC2010-12-20ANDA090268_001
5NDA021199QUIXINTrueSANTEN INC2000-08-18NDA021199_001
6NDA021571IQUIXTrueSANTEN INC2004-03-01NDA021571_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA076826_001RXLEVOFLOXACIN (0.5%)OPHTHALMICSOLUTION/DROPSFalseAT2011-02-10LEVOFLOXACIN
2ANDA077700_001RXLEVOFLOXACIN (0.5%)OPHTHALMICSOLUTION/DROPSTrueAT2010-12-20LEVOFLOXACIN
3ANDA078282_001discontinuedLEVOFLOXACIN (0.5%)OPHTHALMICSOLUTION/DROPSFalse2010-12-20LEVOFLOXACIN
4ANDA090268_001RXLEVOFLOXACIN (0.5%)OPHTHALMICSOLUTION/DROPSFalseAT2010-12-20LEVOFLOXACIN
5NDA021199_001discontinuedLEVOFLOXACIN (0.5%)OPHTHALMICSOLUTION/DROPSFalse2000-08-18QUIXIN
6NDA021571_001discontinuedLEVOFLOXACIN (1.5%)OPHTHALMICSOLUTION/DROPSFalse2004-03-01IQUIX

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1067ea8ec-99a3-4a0b-9116-4ffd6160b24b (view SPL)IQUIX (levofloxacin ophthalmic solution) 1.5%prescriptionHuman PrescriptionVistakon Pharmaceuticals Llc2010-03-183686690145
209b3a912-97f9-45ae-a162-9f45c860dc22 (view SPL)QUIXIN (levofloxacin ophthalmic solution) 0.5%prescriptionHuman PrescriptionVistakon Pharmaceuticals Llc2011-08-175686690135
32bc7f52d-05a5-4dc7-98a8-9412a2c53ea2 (view SPL)Levofloxacin Ophthalmic Solution 0.05%prescriptionHuman PrescriptionHi-Tech Pharmacal Co., Inc.MANUFACTURE2012-09-064503830283
46987500a-2feb-48a9-9d29-89693333a801 (view SPL)Levofloxacin Ophthalmic Solution, 0.5%prescriptionHuman PrescriptionAkornANALYSIS, MANUFACTURE, REPACK2010-12-312174780106
5f79d2ae4-ccfb-49ca-bf0e-e505f3477d30 (view SPL)prescriptionHuman PrescriptionPack Pharmaceuticals LlcMANUFACTURE2011-05-043165710150

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