FDA.reportPublic FDA data

Application 021806

Type
NDA
Sponsor
TEVA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VANDAZOLEMETRONIDAZOLEGEL;VAGINAL0.75%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0245-0860VandazoleMetronidazoleUpsher-Smith Laboratories, LLCNDACurrent
0245-0860VandazoleMetronidazoleUpsher-Smith Laboratories, LLCNDACurrent
0245-0860VandazoleMetronidazoleUpsher-Smith Laboratories, LLCNDACurrent
0245-0860VandazoleMetronidazoleUpsher-Smith Laboratories, LLCNDACurrent
53002-7341VandazoleMetronidazoleRPK Pharmaceuticals, Inc.NDACurrent
70518-2400VandazoleMetronidazoleREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
66233SUPPL2021-02-16
66212SUPPL2021-02-16
28634SUPPL2011-02-10
37685SUPPL2011-02-09
21823ORIG2007-06-29
37684ORIG2005-05-25
28633ORIG2005-05-25