FDA.reportPublic FDA data

Application 011963

Type
NDA
Sponsor
WYETH PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PHOSPHOLINE IODIDEECHOTHIOPHATE IODIDEFOR SOLUTION;OPHTHALMIC0.125%YesYes
002PHOSPHOLINE IODIDEECHOTHIOPHATE IODIDEFOR SOLUTION;OPHTHALMIC0.03%NoNo
003PHOSPHOLINE IODIDEECHOTHIOPHATE IODIDEFOR SOLUTION;OPHTHALMIC0.25%NoNo
004PHOSPHOLINE IODIDEECHOTHIOPHATE IODIDEFOR SOLUTION;OPHTHALMIC0.06%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0046-1065Phospholine Iodideechothiophate iodideWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0046-1065Phospholine Iodideechothiophate iodideWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0046-1065Phospholine Iodideechothiophate iodideWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0046-1065Phospholine Iodideechothiophate iodideWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0046-1065Phospholine Iodideechothiophate iodideWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0046-1065Phospholine Iodideechothiophate iodideWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
48102-053Phospholine Iodideechothiophate iodide for ophthalmic solutionFera Pharmaceuticals, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
69164SUPPL2021-11-01
69168SUPPL2021-10-29
54779SUPPL2018-07-06
295SUPPL2006-03-23
10789SUPPL2006-03-14