FDA.reportPublic FDA data

Application 210821

Type
NDA
Sponsor
BAUSCH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TETRACAINE HYDROCHLORIDETETRACAINE HYDROCHLORIDESOLUTION;OPHTHALMIC0.5%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0187-0920Tetracaine HydrochlorideTetracaine HydrochlorideBausch Health US LLCNDACurrent
24208-092Tetracaine HydrochlorideTetracaine HydrochlorideBausch & Lomb IncorporatedNDACurrent
42702-170Tetracaine HydrochlorideTetracaine HydrochlorideParagon BioTeck, Inc.NDACurrent
68071-5069Tetracaine HydrochlorideTetracaine HydrochlorideNuCare Pharmaceuticals,Inc.NDACurrent
68682-920Tetracaine HydrochlorideTetracaine HydrochlorideOceanside PharmaceuticalsNDACurrent
68682-920Tetracaine HydrochlorideTetracaine HydrochlorideOceanside PharmaceuticalsNDACurrent
68682-920Tetracaine HydrochlorideTetracaine HydrochlorideOceanside PharmaceuticalsNDACurrent
68682-920Tetracaine HydrochlorideTetracaine HydrochlorideOceanside PharmaceuticalsNDACurrent
68682-920Tetracaine HydrochlorideTetracaine HydrochlorideOceanside PharmaceuticalsNDACurrent
70518-2741Tetracaine HydrochlorideTetracaine HydrochlorideREMEDYREPACK INC.NDACurrent
70518-2741Tetracaine HydrochlorideTetracaine HydrochlorideREMEDYREPACK INC.NDACurrent
70518-2741Tetracaine HydrochlorideTetracaine HydrochlorideREMEDYREPACK INC.NDACurrent
70518-2741Tetracaine HydrochlorideTetracaine HydrochlorideREMEDYREPACK INC.NDACurrent
82260-920Tetracaine HydrochlorideTetracaine HydrochlorideBausch & Lomb Americas Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
70256SUPPL2022-02-25
70230SUPPL2022-02-23
58346ORIG2019-04-18
57997ORIG2019-03-14
57988ORIG2019-03-13