FDA Approved Products

Application #TypeSponsorNotesProduct #Drug NameFormStrengthActive IngredientApproval DateMarketing StatusReference Standard
217370NDAALCON LABS INC001TRYPTYRSOLUTION/DROPS;OPHTHALMIC0.003%ACOLTREMON2025-05-28PrescriptionYes
210933NDAALCON LABS INC001EYSUVISSUSPENSION/DROPS;OPHTHALMIC0.25%LOTEPREDNOL ETABONATE2020-10-26PrescriptionYes
208259NDAALCON LABS INC001ROCKLATANSOLUTION/DROPS;OPHTHALMIC0.005%;EQ 0.02% BASELATANOPROST; NETARSUDIL DIMESYLATE2019-03-12PrescriptionYes
210565NDAALCON LABS INC001INVELTYSSUSPENSION/DROPS;OPHTHALMIC1%LOTEPREDNOL ETABONATE2018-08-22PrescriptionYes
208254NDAALCON LABS INC001RHOPRESSASOLUTION/DROPS;OPHTHALMICEQ 0.02% BASENETARSUDIL MESYLATE2017-12-18PrescriptionYes
208151NDAALCON LABS INC001ISOPTO ATROPINESOLUTION/DROPS;OPHTHALMIC1%ATROPINE SULFATE2016-12-01PrescriptionYes
208135NDAALCON LABS001TETRACAINE HYDROCHLORIDESOLUTION;OPHTHALMIC0.5%TETRACAINE HYDROCHLORIDE2016-02-29PrescriptionYes
206276NDAALCON LABS INC001PATADAY ONCE DAILY RELIEFSOLUTION/DROPS;OPHTHALMICEQ 0.7% BASEOLOPATADINE HYDROCHLORIDE2015-01-30Over-the-counterYes
207926NDAALCON001PHENYLEPHRINE HYDROCHLORIDESOLUTION/DROPS;OPHTHALMIC2.5%PHENYLEPHRINE HYDROCHLORIDE2015-01-15PrescriptionNo
002PHENYLEPHRINE HYDROCHLORIDESOLUTION/DROPS;OPHTHALMIC10%PHENYLEPHRINE HYDROCHLORIDE2015-01-15PrescriptionNo
204251NDAALCON LABS INC001SIMBRINZASUSPENSION/DROPS;OPHTHALMIC0.2%;1%BRIMONIDINE TARTRATE; BRINZOLAMIDE2013-04-19PrescriptionYes
077200ANDAALCON PHARMS LTD001ZADITORSOLUTION/DROPS;OPHTHALMICEQ 0.025% BASEKETOTIFEN FUMARATE2008-09-02Over-the-counterYes
022193NDAALCON PHARMS LTD001NAVSTELSOLUTION;IRRIGATION0.154MG/ML;0.92MG/ML;0.2MG/ML;0.184MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/MLCALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; OXIGLUTATIONE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE2008-07-24DiscontinuedNo
022223NDAALCON RES001TRIESENCEINJECTABLE; SUSPENSION40MGMLTRIAMCINOLONE ACETONIDE2007-11-29PrescriptionNo
021980NDAALCON LABS INC001FLUORESCITEINJECTABLE;INTRAVENOUSEQ 500MG BASE/5ML (EQ 100MG BASE/ML)FLUORESCEIN SODIUM2006-03-28PrescriptionYes
021545NDAALCON LABS INC001PATADAY ONCE DAILY RELIEFSOLUTION/DROPS;OPHTHALMICEQ 0.2% BASEOLOPATADINE HYDROCHLORIDE2004-12-22Over-the-counterYes
021257NDAALCON PHARMS LTD001TRAVATANSOLUTION/DROPS;OPHTHALMIC0.004% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TRAVOPROST2001-03-16DiscontinuedNo
021114NDAALCON PHARMS LTD001BETAXONSUSPENSION/DROPS;OPHTHALMICEQ 0.5% BASELEVOBETAXOLOL HYDROCHLORIDE2000-02-23DiscontinuedNo
021066NDAALCON PHARMA002ZADITORSOLUTION/DROPS;OPHTHALMICEQ 0.025% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**KETOTIFEN FUMARATE1999-07-02DiscontinuedNo
020742NDAALCON001BSSSOLUTION;IRRIGATION0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/MLCALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM CITRATE1997-12-10PrescriptionYes
020619NDAALCON001BETOPTIC PILOSUSPENSION/DROPS;OPHTHALMICEQ 0.25% BASE;1.75%BETAXOLOL HYDROCHLORIDE; PILOCARPINE HYDROCHLORIDE1997-04-17DiscontinuedNo
020688NDAALCON LABS INC001PATADAY TWICE DAILY RELIEFSOLUTION/DROPS;OPHTHALMICEQ 0.1% BASEOLOPATADINE HYDROCHLORIDE1996-12-18Over-the-counterYes
074851ANDAALCON LABS INC001LEVOBUNOLOL HYDROCHLORIDESOLUTION/DROPS;OPHTHALMIC0.25%LEVOBUNOLOL HYDROCHLORIDE1996-10-28DiscontinuedNo
020226NDAALCON001NAPHCON-ASOLUTION/DROPS;OPHTHALMIC0.025%;0.3%NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE1994-06-08Over-the-counterYes
063176ANDAALCON PHARMS LTD001TOBRAMYCINSOLUTION/DROPS;OPHTHALMIC0.3%TOBRAMYCIN1994-05-25DiscontinuedNo
087771ANDAALCON001CETAPREDOINTMENT;OPHTHALMIC0.25%;10%PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM1993-08-06DiscontinuedNo
081043ANDAALCON PHARMS LTD001PREDNISOLONE SODIUM PHOSPHATESOLUTION/DROPS;OPHTHALMICEQ 0.11% PHOSPHATEPREDNISOLONE SODIUM PHOSPHATE1991-10-24DiscontinuedNo
081044ANDAALCON PHARMS LTD001PREDNISOLONE SODIUM PHOSPHATESOLUTION/DROPS;OPHTHALMICEQ 0.9% PHOSPHATEPREDNISOLONE SODIUM PHOSPHATE1991-10-24DiscontinuedNo
089162ANDAALCON PHARMS LTD001CYCLOPENTOLATE HYDROCHLORIDESOLUTION/DROPS;OPHTHALMIC1%CYCLOPENTOLATE HYDROCHLORIDE1991-01-24DiscontinuedNo
089172ANDAALCON PHARMS LTD001TROPICAMIDESOLUTION/DROPS;OPHTHALMIC1%TROPICAMIDE1990-12-28DiscontinuedNo
019387NDAALCON001PROFENALSOLUTION/DROPS;OPHTHALMIC1%SUPROFEN1988-12-23DiscontinuedNo
089068ANDAALCON PHARMS LTD001SULFACETAMIDE SODIUMSOLUTION/DROPS;OPHTHALMIC30%SULFACETAMIDE SODIUM1987-05-05DiscontinuedNo
018634NDAALCON PHARMS LTD001BETADINESOLUTION/DROPS;OPHTHALMIC5%POVIDONE-IODINE1986-12-17PrescriptionYes
062721ANDAALCON PHARMS LTD001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONESUSPENSION/DROPS;OPHTHALMIC0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLDEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE1986-11-17DiscontinuedNo
062714ANDAALCON PHARMS LTD001NEOMYCIN SULFATE-DEXAMETHASONE SODIUM PHOSPHATESOLUTION/DROPS;OPHTHALMICEQ 0.1% PHOSPHATE;EQ 3.5MG BASE/MLDEXAMETHASONE SODIUM PHOSPHATE; NEOMYCIN SULFATE1986-07-21DiscontinuedNo
062523ANDAALCON PHARMS LTD001GENTAMICIN SULFATESOLUTION/DROPS;OPHTHALMICEQ 0.3% BASEGENTAMICIN SULFATE1985-11-25DiscontinuedNo
062628ANDAALCON001CHLORAMPHENICOLSOLUTION/DROPS;OPHTHALMIC0.5%CHLORAMPHENICOL1985-09-25DiscontinuedNo
062339ANDAALCON001STATROLSOLUTION/DROPS;OPHTHALMICEQ 3.5MG BASE/ML;16,250 UNITS/MLNEOMYCIN SULFATE; POLYMYXIN B SULFATE1984-11-30DiscontinuedNo
018796NDAALCON001PILOPINE HSGEL;OPHTHALMIC4%PILOCARPINE HYDROCHLORIDE1984-10-01DiscontinuedNo
018469NDAALCON001BSS PLUSSOLUTION;IRRIGATION0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/MLCALCIUM CHLORIDE; DEXTROSE; GLUTATHIONE DISULFIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE1981-10-28PrescriptionYes
087547ANDAALCON001ISOPTO CETAPREDSUSPENSION;OPHTHALMIC0.25%;10%PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM1981-07-21DiscontinuedNo
084300ANDAALCON LABS INC001CYCLOMYDRILSOLUTION/DROPS;OPHTHALMIC0.2%;1%CYCLOPENTOLATE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE1975-09-12PrescriptionYes
084306ANDAALCON LABS INC001MYDRIACYLSOLUTION/DROPS;OPHTHALMIC1%TROPICAMIDE1974-12-06PrescriptionYes
084108ANDAALCON LABS INC001CYCLOGYLSOLUTION/DROPS;OPHTHALMIC2%CYCLOPENTOLATE HYDROCHLORIDE1974-07-31PrescriptionYes
084109ANDAALCON LABS INC001CYCLOGYLSOLUTION/DROPS;OPHTHALMIC0.5%CYCLOPENTOLATE HYDROCHLORIDE1974-07-31PrescriptionYes
084110ANDAALCON LABS INC001CYCLOGYLSOLUTION/DROPS;OPHTHALMIC1%CYCLOPENTOLATE HYDROCHLORIDE1974-07-31PrescriptionYes
061648ANDAALCON001ECONOCHLOROINTMENT;OPHTHALMIC1%CHLORAMPHENICOL1974-05-14DiscontinuedNo
050344NDAALCON002STATROLOINTMENT;OPHTHALMICEQ 3.5MG BASE/GM;10,000 UNITS/GMNEOMYCIN SULFATE; POLYMYXIN B SULFATE1974-03-12DiscontinuedNo
050456NDAALCON001STATROLSOLUTION/DROPS;OPHTHALMICEQ 3.5MG BASE/ML;16,250 UNITS/MLNEOMYCIN SULFATE; POLYMYXIN B SULFATE1974-03-12DiscontinuedNo
080229ANDAALCON001NAPHCON FORTESOLUTION/DROPS;OPHTHALMIC0.1%NAPHAZOLINE HYDROCHLORIDE1974-03-06DiscontinuedNo
017063NDAALCON001ISMOTICSOLUTION;ORAL100GM/220MLISOSORBIDE1974-01-30DiscontinuedNo
083342ANDAALCON001MAXIDEXOINTMENT;OPHTHALMICEQ 0.05% PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATE1973-10-23DiscontinuedNo
061645ANDAALCON001ECONOCHLORSOLUTION/DROPS;OPHTHALMIC0.5%CHLORAMPHENICOL1973-04-26DiscontinuedNo
016968NDAALCON001MIOSTATSOLUTION;INTRAOCULAR0.01%CARBACHOL1972-09-28PrescriptionYes
080021ANDAALCON001CETAMIDEOINTMENT;OPHTHALMIC10%SULFACETAMIDE SODIUM1972-09-27DiscontinuedNo
080027ANDAALCON LABS INC001ALCAINESOLUTION/DROPS;OPHTHALMIC0.5%PROPARACAINE HYDROCHLORIDE1971-12-22PrescriptionNo
080020ANDAALCON002ISOPTO CETAMIDESOLUTION/DROPS;OPHTHALMIC15%SULFACETAMIDE SODIUM1971-05-05DiscontinuedNo
091574ANDAALCON001BRIMONIDINE TARTRATE; TIMOLOL MALEATESOLUTION; OPHTHALMIC0.2%; 0.5%BRIMONIDINE TARTRATE; TIMOLOL MALEATENone (Tentative Approval)No
005319NDAALCON001PANTOPAQUEINJECTABLE;INJECTION100%IOPHENDYLATEDiscontinuedNo
014169NDAALCON001DENDRIDSOLUTION/DROPS;OPHTHALMIC0.1%IDOXURIDINE1963-06-28DiscontinuedNo
012111NDAALCON002MYDRIACYLSOLUTION/DROPS;OPHTHALMIC0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TROPICAMIDE1960-02-23DiscontinuedNo
004MYDRIACYLSOLUTION/DROPS;OPHTHALMIC1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TROPICAMIDE1960-02-23DiscontinuedNo