Phenylephrine Ophthalmic Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Akorn (2015-01-13)
Oldest Current Product
1990-09-30
License(s)
NDA, UNAPPROVED DRUG OTHER MARKETING CATEGORY
RxNORM
OPHTHALMIC SOLUTION\PHENYLEPHRINE
FDAOB
OPHTHALMIC\SOLUTION_DROPS\PHENYLEPHRINE HYDROCHLORIDE
SPL Active
OPHTHALMIC\SOLUTION/DROPS\PHENYLEPHRINE HYDROCHLORIDE
OPHTHALMIC\SOLUTION\PHENYLEPHRINE HYDROCHLORIDE
SPL Moiety
OPHTHALMIC\SOLUTION/DROPS\PHENYLEPHRINE
OPHTHALMIC\SOLUTION\PHENYLEPHRINE

product(s) by strength(s)

phenylephrine hydrochloride 100 mg/ml ophthalmic solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1172380520UNAPPROVED DRUG OTHER MARKETING CATEGORYHub Pharmaceuticals2011-01-01PHENYLEPHRINE HYDROCHLORIDEOPHTHALMICSOLUTION/DROPSfbb72cf5-c783-4795-ae12-eb15c6087a90
2174780206NDAAkorn2015-01-15PHENYLEPHRINE HYDROCHLORIDEOPHTHALMICSOLUTION/DROPSNDA20792649558551-cbed-4518-a6d4-16cfd893eab0

phenylephrine hydrochloride 25 mg/ml ophthalmic solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1427020102NDAParagon Bioteck, Inc.2013-04-15PHENYLEPHRINE HYDROCHLORIDEOPHTHALMICSOLUTION/DROPSNDA203510a4d3fe20-f063-11e0-ac29-0002a5d5c51b
2613140342UNAPPROVED DRUG OTHER MARKETING CATEGORYSandoz Inc2000-06-30PHENYLEPHRINE HYDROCHLORIDEOPHTHALMICSOLUTION602e866f-18de-f904-a1f4-f6a1a94a9a41

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productspl
1545691657UNAPPROVED DRUG OTHER MARKETING CATEGORYA-S Medication Solutions Llc1991-07-01PHENYLEPHRINE HYDROCHLORIDEOPHTHALMICSOLUTION/DROPS174780200135c6904-f581-4535-bdec-5c3592c2b3ba
2636291594UNAPPROVED DRUG OTHER MARKETING CATEGORYBryant Ranch Prepack1990-09-30PHENYLEPHRINE HYDROCHLORIDEOPHTHALMICSOLUTION242080740cbe3834f-6eff-49d9-9e08-42acd2c20eb5

application(s)

#idtitleapplicantapprovedpatentapproved drug
1NDA203510PHENYLEPHRINE HYDROCHLORIDEPARAGON BIOTECK INC2013-03-21p8859623, DILATION OF THE PUPILNDA203510_001, NDA203510_002
2NDA207926PHENYLEPHRINE HYDROCHLORIDEAKORN INC2015-01-15NDA207926_001, NDA207926_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA203510_001RXPHENYLEPHRINE HYDROCHLORIDE (2.5%)OPHTHALMICSOLUTION/DROPSTrue2013-03-21PHENYLEPHRINE HYDROCHLORIDE
2NDA203510_002RXPHENYLEPHRINE HYDROCHLORIDE (10%)OPHTHALMICSOLUTION/DROPSTrue2013-03-21PHENYLEPHRINE HYDROCHLORIDE
3NDA207926_001RXPHENYLEPHRINE HYDROCHLORIDE (2.5%)OPHTHALMICSOLUTION/DROPSTrue2015-01-15PHENYLEPHRINE HYDROCHLORIDE
4NDA207926_002RXPHENYLEPHRINE HYDROCHLORIDE (10%)OPHTHALMICSOLUTION/DROPSTrue2015-01-15PHENYLEPHRINE HYDROCHLORIDE

patent(s)

#idexpiration dateapplication(s)
1p8859623 (view patent)2033-11-14NDA203510

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1135c6904-f581-4535-bdec-5c3592c2b3ba (view SPL)Phenylephrine HydrochlorideOphthalmic Solution, USPprescriptionHuman PrescriptionA-S Medication Solutions Llcrelabel2013-06-291545691657
221525f9e-f3a2-4871-81bf-90a0686968f0 (view SPL)Sterile Phenylephrine Hydrochloride Ophthalmic Solution 2.5% USP Rx OnlyprescriptionHuman PrescriptionHub Pharmaceuticals2011-01-011172380193
349558551-cbed-4518-a6d4-16cfd893eab0 (view SPL)These highlights do not include all the information needed to use PHENYLEPHRINE HYDROCHLORIDE OPHTHALMIC SOLUTION, USP safely and effectively. See full prescribing information for PHENYLEPHRINE HYDROCHLORIDE OPHTHALMIC SOLUTION, USP.PHENYLEPHRINE HYDROCHLORIDE ophthalmic solution, USP 2.5% and 10%.Initial U.S. Approval: 1939prescriptionHuman PrescriptionAkornANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2015-01-133174780206, 174780201
4602e866f-18de-f904-a1f4-f6a1a94a9a41 (view SPL)Phenylephrine Hydrochloride Ophthalmic Solution, 2.5%Vasoconstrictor and MydriaticFor Use in OphthalmologyprescriptionHuman PrescriptionSandoz IncMANUFACTURE2011-09-211613140342
5a4d3fe20-f063-11e0-ac29-0002a5d5c51b (view SPL)These highlights do not include all the information needed to use Phenylephrine Hydrochloride Ophthalmic Solution 2.5% and 10% safely and effectively. See full prescribing information for Phenylephrine Hydrochloride Ophthalmic Solution 2.5% and 10% Initial U.S. Approval:prescriptionHuman PrescriptionParagon Bioteck, Inc.2013-03-202427020102, 427020103
6cbe3834f-6eff-49d9-9e08-42acd2c20eb5 (view SPL)Phenylephrine Hydrochloride Ophthalmic Solution USP, 2.5%(Sterile)Rx onlyprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2013-04-251001636291594
7fbb72cf5-c783-4795-ae12-eb15c6087a90 (view SPL)Sterile Phenylephrine Hydrochloride Ophthalmic Solution 10% USP Rx OnlyprescriptionHuman PrescriptionHub Pharmaceuticals2011-01-011172380520

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