FDA.reportPublic FDA data

Application 021478

Type
NDA
Sponsor
BAUSCH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZOVIRAXACYCLOVIRCREAM;TOPICAL5%YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-3630AcycloviracyclovirTeva Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
0093-3630AcycloviracyclovirTeva Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
0093-3630AcycloviracyclovirTeva Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
0093-3630AcycloviracyclovirTeva Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
0187-0994ZoviraxacyclovirValeant Pharmaceuticals North America LLCNDACurrent
0187-0994ZoviraxacyclovirBausch Health Americas, Inc.NDACurrent
0187-0994ZoviraxacyclovirBausch Health US, LLCNDACurrent
0187-0994ZoviraxacyclovirBausch Health US, LLCNDACurrent
42254-149ZOVIRAXacyclovirRebel Distributors CorpNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
65777SUPPL2020-12-29
65759SUPPL2020-12-28
53727SUPPL2018-04-18
5495SUPPL2014-04-03
15563SUPPL2014-04-02
21683SUPPL2006-10-25
5494ORIG2004-07-01
27895SUPPL2004-02-02
42188ORIG2003-07-08
37034ORIG2003-04-09