Application 022278

Type
NDA
Sponsor
DORC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MEMBRANEBLUETRYPAN BLUESOLUTION;OPHTHALMIC0.15%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68803-672MEMBRANEBLUEtrypan blueDutch Ophthalmic Research Center (International) B.V.NDACurrent
68803-672MEMBRANEBLUEtrypan blueDutch Ophthalmic Research Center (International) B.V.NDACurrent
68803-672MEMBRANEBLUEtrypan blueDutch Ophthalmic Research Center (International) B.V.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84199SUPPL 2025-11-18
84189SUPPL 2025-11-18
38493SUPPL2014-09-19
7163SUPPL2014-09-17
21980ORIG2009-12-16
38492ORIG2009-02-24
7162ORIG2009-02-24