FDA.reportPublic FDA data

Application 020310

Type
NDA
Sponsor
KRAMER

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NIZORAL A-DKETOCONAZOLESHAMPOO;TOPICAL1%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50580-895NizoralKetoconazoleJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionNDACurrent
50580-895NizoralKetoconazoleJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionNDACurrent
55505-191NizoralKetoconazoleKramer LaboratoriesNDA AUTHORIZED GENERICCurrent
55505-191NizoralKetoconazoleKramer LaboratoriesNDA AUTHORIZED GENERICCurrent
55505-191NizoralKetoconazoleKramer LaboratoriesNDA AUTHORIZED Current
55505-192NizoralKetoconazoleKramer LaboratoriesNDACurrent
55505-192NizoralKetoconazoleKramer LaboratoriesNDACurrent
55505-192NizoralKetoconazoleKramer LaboratoriesNDACurrent
55505-192NizoralKetoconazoleKramer LaboratoriesNDACurrent
55505-192NizoralKetoconazoleKramer LaboratoriesNDACurrent
55505-196NizoralKetoconazoleKramer LaboratoriesNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85812SUPPL 2026-05-04
85811SUPPL 2026-05-04
84218SUPPL 2025-11-19
84217SUPPL 2025-11-19
81113SUPPL 2025-02-06
81037SUPPL 2025-02-06
78993SUPPL 2024-07-08
78992SUPPL 2024-07-08
77848SUPPL 2024-03-15
77842SUPPL 2024-03-15
75660SUPPL 2023-10-03
75642SUPPL 2023-10-03
73262SUPPL2023-01-20
73257SUPPL2023-01-20
71101SUPPL2022-05-19
71074SUPPL2022-05-16
66084SUPPL2021-02-03
62620SUPPL2020-04-21
62619SUPPL2020-04-21
61073SUPPL2019-11-27
61072SUPPL2019-11-27
56623SUPPL2018-12-04
23574ORIG2014-02-07
24761SUPPL2010-09-21
20594ORIG1997-10-10