FDA.reportPublic FDA data

Application 050514

Type
NDA
Sponsor
NOVARTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NATACYNNATAMYCINSUSPENSION;OPHTHALMIC5%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0065-0645NATACYNnatamycinAlcon Laboratories, Inc.NDACurrent
0065-0645NATACYNnatamycinAlcon Laboratories, Inc.NDACurrent
0065-0645NATACYNnatamycinAlcon Laboratories, Inc.NDACurrent
0065-0645NATACYNnatamycinAlcon Laboratories, Inc.NDACurrent
0065-0645NATACYNnatamycinAlcon Laboratories, Inc.NDACurrent
71776-005NATACYNnatamycinEyevance PharmaceuticalsNDACurrent
71776-005NATACYNnatamycinEyevance Pharmaceuticals, LLCNDACurrent
71776-005NATACYNnatamycinEyevance Pharmaceuticals, LLCNDACurrent
71776-005NATACYNnatamycinEyevance Pharmaceuticals, LLCNDACurrent
71776-005NATACYNnatamycinEyevance Pharmaceuticals, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84200SUPPL 2025-11-18
84188SUPPL 2025-11-18
68757SUPPL2021-09-24
7775SUPPL2008-07-23
17849SUPPL2008-07-22