Povidone-Iodine Ophthalmic Solution

Brand(s)
Betadine
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Alcon Laboratories, Inc. (2011-07-11)
Oldest Current Product
2000-04-01
License(s)
NDA
RxNORM
OPHTHALMIC SOLUTION\POVIDONE-IODINE
FDAOB
OPHTHALMIC\SOLUTION_DROPS\POVIDONE-IODINE
SPL Active
OPHTHALMIC\SOLUTION\POVIDONE-IODINE
SPL Moiety
OPHTHALMIC\SOLUTION\IODINE

product(s) by strength(s)

povidone-iodine 50 mg/ml ophthalmic solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000650411BetadineNDAAlcon Laboratories, Inc.2000-04-01POVIDONE-IODINEOPHTHALMICSOLUTIONNDA018634b026de1b-9949-4557-ac49-c7b0038c24cd

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1422540006BetadineNDARebel Distributors Corp2000-04-01POVIDONE-IODINEOPHTHALMICSOLUTION000650411NDA01863472287bb4-3f70-4e12-aaf3-cfff48e044f8

application(s)

#idtitleapplicantapprovedapproved drug
1NDA018634BETADINEALCON PHARMACEUTICALS LTD1986-12-17NDA018634_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA018634_001RXPOVIDONE-IODINE (5%)OPHTHALMICSOLUTION/DROPSTrue1986-12-17BETADINE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
172287bb4-3f70-4e12-aaf3-cfff48e044f8 (view SPL)Betadine 5%Sterile OphthalmicPrep Solution(povidone-iodine ophthalmic solution)(0.5% available iodine)prescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2011-10-251422540006
2b026de1b-9949-4557-ac49-c7b0038c24cd (view SPL)Betadine 5%Sterile OphthalmicPrep Solution(povidone-iodine ophthalmic solution)(0.5% available iodine)prescriptionHuman PrescriptionAlcon Laboratories, Inc.MANUFACTURE2011-07-114000650411

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