FDA.reportPublic FDA data

Application 020901

Type
NDA
Sponsor
GALDERMA LABS LP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METROLOTIONMETRONIDAZOLELOTION;TOPICAL0.75%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0299-3838MetroLotionmetronidazoleGalderma Laboratories, L.P.NDACurrent
66993-961metronidazolemetronidazolePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
13699SUPPL2004-05-27
3693SUPPL2004-05-26
21051ORIG1999-07-08
35602ORIG1998-11-24
26145ORIG1998-11-24