FDA.reportPublic FDA data

Application 206976

Type
NDA
Sponsor
IBSA INST BIO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LICARTDICLOFENAC EPOLAMINESYSTEM;TOPICAL1.3%YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
71858-0305LICARTdiclofenac epolamineIBSA Pharma Inc.NDACurrent
71858-0305LICARTdiclofenac epolamineIBSA Pharma Inc.NDACurrent
71858-0305LICARTdiclofenac epolamineIBSA Pharma Inc.NDACurrent
71858-0305LICARTdiclofenac epolamineIBSA Pharma Inc.NDACurrent
71858-0305LICARTdiclofenac epolamineIBSA Pharma Inc.NDACurrent
71858-0305LICARTdiclofenac epolamineIBSA Pharma Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85597SUPPL 2026-03-31
85578SUPPL 2026-03-30
80398SUPPL 2024-11-25
80397SUPPL 2024-11-25
80316SUPPL 2024-11-22
79314SUPPL 2024-08-06
79311SUPPL 2024-08-05
67377SUPPL2021-05-03
67376SUPPL2021-05-03
67290SUPPL2021-04-30
63080SUPPL2020-05-18
63079SUPPL2020-05-18
63030SUPPL2020-05-15
61560SUPPL2020-01-14
57568ORIG2019-02-13
56946ORIG2018-12-21
56850ORIG2018-12-20
56846ORIG2018-12-20