FDA.reportPublic FDA data

Application 022483

Type
NDA
Sponsor
BAUSCH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZYCLARAIMIQUIMODCREAM;TOPICAL3.75%YesYes
002ZYCLARAIMIQUIMODCREAM;TOPICAL2.5%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-3133ImiquimodimiquimodTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3133ImiquimodimiquimodTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
63629-8818ImiquimodimiquimodBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-8818ImiquimodimiquimodBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
68682-272ImiquimodimiquimodOceanside PharmacueticalsNDACurrent
68682-272ImiquimodimiquimodOceanside PharmacueticalsNDACurrent
68682-272ImiquimodimiquimodOceanside PharmacueticalsNDACurrent
68682-272ImiquimodimiquimodOceanside PharmacueticalsNDA AUTHORIZED GENERICCurrent
99207-270ZyclaraimiquimodBausch Health US, LLCNDACurrent
99207-270ZyclaraimiquimodBausch Health US, LLCNDACurrent
99207-270ZyclaraimiquimodBausch Health US, LLCNDACurrent
99207-270ZyclaraimiquimodValeant Pharmaceuticals North America LLCNDACurrent
99207-270ZyclaraimiquimodValeant Pharmaceuticals North America LLCNDACurrent
99207-270ZyclaraimiquimodBausch Health US, LLCNDACurrent
99207-270ZyclaraimiquimodBausch Health US, LLCNDACurrent
99207-270ZyclaraimiquimodBausch Health US, LLCNDACurrent
99207-271ZyclaraimiquimodBausch Health US, LLCNDACurrent
99207-271ZyclaraimiquimodBausch Health US, LLCNDACurrent
99207-271ZyclaraimiquimodBausch Health US, LLCNDACurrent
99207-271ZyclaraimiquimodValeant Pharmaceuticals North America LLCNDACurrent
99207-271ZyclaraimiquimodValeant Pharmaceuticals North America LLCNDACurrent
99207-271ZyclaraimiquimodBausch Health US, LLCNDACurrent
99207-271ZyclaraimiquimodBausch Health US, LLCNDACurrent
99207-271ZyclaraimiquimodBausch Health US, LLCNDACurrent
99207-276ZyclaraimiquimodBausch Health US, LLCNDACurrent
99207-276ZyclaraimiquimodBausch Health US, LLCNDACurrent
99207-276ZyclaraimiquimodBausch Health US, LLCNDACurrent
99207-276ZyclaraimiquimodBausch Health US, LLCNDACurrent
99207-276ZyclaraimiquimodValeant Pharmaceuticals North America LLCNDACurrent
99207-276ZyclaraimiquimodValeant Pharmaceuticals North America LLCNDACurrent
99207-276ZyclaraimiquimodBausch Health US, LLCNDACurrent
99207-276ZyclaraimiquimodBausch Health US, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79646SUPPL 2024-09-18
79638SUPPL 2024-09-17
29770SUPPL2012-02-17
17637SUPPL2012-02-17
7453SUPPL2011-10-03
38756SUPPL2011-09-30
7454SUPPL2011-07-19
17636SUPPL2011-07-18
17635SUPPL2011-03-28
7452SUPPL2011-03-25
17634ORIG2011-02-18
24319ORIG2011-02-17
22033ORIG2010-12-01
7451ORIG2010-03-29