FDA.reportPublic FDA data

Application 077264

Type
ANDA
Sponsor
TOLMAR

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-7077MetronidazoleMetronidazoleSandoz Inc.ANDACurrent
0781-7077MetronidazoleMetronidazoleSandoz Inc.ANDACurrent
50090-1012MetronidazoleMetronidazoleA-S Medication SolutionsANDACurrent
50090-1012MetronidazoleMetronidazoleA-S Medication SolutionsANDACurrent
53002-7340MetronidazoleMetronidazoleRPK Pharmaceuticals, Inc.ANDACurrent
53002-7340MetronidazoleMetronidazoleRPK Pharmaceuticals, Inc.ANDACurrent
63629-8731MetronidazoleMetronidazoleBryant Ranch PrepackANDACurrent
63629-8731MetronidazoleMetronidazoleBryant Ranch PrepackANDACurrent
68071-5009MetronidazoleMetronidazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5009MetronidazoleMetronidazoleNuCare Pharmaceuticals,Inc.ANDACurrent
70518-0539MetronidazoleMetronidazoleREMEDYREPACK INC.ANDACurrent
70518-0539MetronidazoleMetronidazoleREMEDYREPACK INC.ANDACurrent
70518-0539MetronidazoleMetronidazoleREMEDYREPACK INC.ANDACurrent
70518-0539MetronidazoleMetronidazoleREMEDYREPACK INC.ANDACurrent
70518-0539MetronidazoleMetronidazoleREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9026ORIG2006-11-06