FDA.reportPublic FDA data

Application 208135

Type
NDA
Sponsor
ALCON LABS

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0065-0741Tetracaine Hydrochloridetetracaine hydrochlorideAlcon Laboratories, Inc.NDACurrent
0065-0741Tetracaine Hydrochloridetetracaine hydrochlorideAlcon Laboratories, Inc.NDACurrent
0065-0741Tetracaine Hydrochloridetetracaine hydrochlorideAlcon Laboratories, Inc.NDACurrent
0065-0741Tetracaine Hydrochloridetetracaine hydrochlorideAlcon Laboratories, Inc.NDACurrent
0065-0741Tetracaine Hydrochloridetetracaine hydrochlorideAlcon Laboratories, Inc.NDACurrent
68071-5079Tetracaine Hydrochloridetetracaine hydrochlorideNuCare Pharmaceuticals,Inc.NDACurrent
68071-5079Tetracaine Hydrochloridetetracaine hydrochlorideNuCare Pharmaceuticals,Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
70364SUPPL2022-03-02
70311SUPPL2022-03-01
46037ORIG2016-10-27
46035ORIG2016-10-27
40618ORIG2016-03-03
32893ORIG2016-03-02
51682ORIG1900-01-01
51681ORIG1900-01-01
51680ORIG1900-01-01
51679ORIG1900-01-01