Naphazoline Ophthalmic Solution

Brand(s)
AK-Con
Category(s)
otc, prescription
SPL Type(s)
Human OTC, Human Prescription
Master SPL
Sato Pharmaceutical Co., Ltd. (2014-02-13)
Oldest Current Product
1974-08-22
License(s)
ANDA, OTC MONOGRAPH FINAL
RxNORM
OPHTHALMIC SOLUTION\NAPHAZOLINE
FDAOB
OPHTHALMIC\SOLUTION_DROPS\NAPHAZOLINE HYDROCHLORIDE
SPL Active
OPHTHALMIC\SOLUTION/DROPS\NAPHAZOLINE HYDROCHLORIDE
OPHTHALMIC\SOLUTION\NAPHAZOLINE HYDROCHLORIDE
SPL Moiety
OPHTHALMIC\SOLUTION/DROPS\NAPHAZOLINE
OPHTHALMIC\SOLUTION\NAPHAZOLINE

product(s) by strength(s)

naphazoline hydrochloride 0.12 mg/ml ophthalmic solution

product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1498730044OTC MONOGRAPH FINALSato Pharmaceutical Co., Ltd.1989-05-31NAPHAZOLINE HYDROCHLORIDEOPHTHALMICSOLUTION/DROPSe0317a10-7b94-41c8-8d2b-0e3b6fc4ef60

naphazoline hydrochloride 1 mg/ml ophthalmic solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1174780216ANDAAkorn1995-12-19NAPHAZOLINE HYDROCHLORIDEOPHTHALMICSOLUTION/DROPSANDA0835906665d0e3-e35b-45e4-b0fe-24c25e26f5ad

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950915AK-ConANDARebel Distributors Corp1974-08-22NAPHAZOLINE HYDROCHLORIDEOPHTHALMICSOLUTION174780216ANDA083590297f0888-729c-4ce6-8779-6b239abf3c93
2545692657ANDAA-S Medication Solutions Llc1995-12-19NAPHAZOLINE HYDROCHLORIDEOPHTHALMICSOLUTION/DROPS174780216ANDA083590747c20e4-f594-4894-941d-7ed59cf990cb
3631870412ANDAProficient Rx Lp1995-12-19NAPHAZOLINE HYDROCHLORIDEOPHTHALMICSOLUTION/DROPS174780216ANDA083590eee62a16-5d68-4639-8aec-63189f3afe60
4687880446AK-ConANDAPreferred Pharmaceuticals, Inc.2005-03-24NAPHAZOLINE HYDROCHLORIDEOPHTHALMICSOLUTION/DROPS174780216ANDA0835908d353143-cd29-4a5f-9d67-293a6322e088
5687889680ANDAPreferred Pharmaceuticals, Inc.2013-04-22NAPHAZOLINE HYDROCHLORIDEOPHTHALMICSOLUTION/DROPS174780216ANDA083590484749dc-5abc-4f55-9e46-ac6b71c81026

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040073NAFAZAIRTrueBAUSCH AND LOMB PHARMACEUTICALS INC1994-05-25ANDA040073_001
2ANDA080229NAPHCON FORTETrueALCON LABORATORIES INCANDA080229_001
3ANDA080235VASOCONTrueNOVARTIS PHARMACEUTICALS CORP1983-03-24ANDA080235_002
4ANDA080248ALBALONTrueALLERGAN INCANDA080248_001
5ANDA083590NAPHAZOLINE HYDROCHLORIDEAKORN INCANDA083590_001
6ANDA087506OPCONTrueBAUSCH AND LOMB PHARMACEUTICALS INCANDA087506_001
7ANDA088101NAFAZAIRTruePHARMAFAIR INC1983-04-15ANDA088101_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA040073_001discontinuedNAPHAZOLINE HYDROCHLORIDE (0.1%)OPHTHALMICSOLUTION/DROPSFalse1994-05-25NAFAZAIR
2ANDA080229_001discontinuedNAPHAZOLINE HYDROCHLORIDE (0.1%)OPHTHALMICSOLUTION/DROPSFalseNAPHCON FORTE
3ANDA080235_002discontinuedNAPHAZOLINE HYDROCHLORIDE (0.1%)OPHTHALMICSOLUTION/DROPSFalse1983-03-24VASOCON
4ANDA080248_001discontinuedNAPHAZOLINE HYDROCHLORIDE (0.1%)OPHTHALMICSOLUTION/DROPSFalseALBALON
5ANDA083590_001RXNAPHAZOLINE HYDROCHLORIDE (0.1%)OPHTHALMICSOLUTION/DROPSTrueNAPHAZOLINE HYDROCHLORIDE
6ANDA087506_001discontinuedNAPHAZOLINE HYDROCHLORIDE (0.1%)OPHTHALMICSOLUTION/DROPSFalseOPCON
7ANDA088101_001discontinuedNAPHAZOLINE HYDROCHLORIDE (0.1%)OPHTHALMICSOLUTION/DROPSFalse1983-04-15NAFAZAIR

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1297f0888-729c-4ce6-8779-6b239abf3c93 (view SPL)ALBALON (naphazoline hydrochloride ophthalmic solution, USP) 0.1%prescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2011-03-301216950915
2484749dc-5abc-4f55-9e46-ac6b71c81026 (view SPL)Naphazoline HydrochlorideOphthalmic Solution USP, 0.1%prescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.RELABEL2013-04-221687889680
36665d0e3-e35b-45e4-b0fe-24c25e26f5ad (view SPL)Naphazoline HydrochlorideOphthalmic Solution USP, 0.1%prescriptionHuman PrescriptionAkornANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2012-03-091174780216
4747c20e4-f594-4894-941d-7ed59cf990cb (view SPL)Naphazoline HydrochlorideOphthalmic Solution USP, 0.1%prescriptionHuman PrescriptionA-S Medication Solutions Llcrelabel2013-10-251545692657
58d353143-cd29-4a5f-9d67-293a6322e088 (view SPL)Naphazoline Hydrochloride Ophthalmic Solution USP, 0.1%prescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.RELABEL2014-06-174687880446
6e0317a10-7b94-41c8-8d2b-0e3b6fc4ef60 (view SPL)DRUG FACTSotcHuman OTCSato Pharmaceutical Co., Ltd.label, manufacture, pack2014-02-134498730044
7eee62a16-5d68-4639-8aec-63189f3afe60 (view SPL)Naphazoline Hydrochloride Ophthalmic Solution USP, 0.1%prescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2014-03-271631870412

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