FDA.reportPublic FDA data

Application 208681

Type
ANDA
Sponsor
ORIT LABS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METRONIDAZOLEMETRONIDAZOLETABLET;ORAL250MGNoNo
002METRONIDAZOLEMETRONIDAZOLETABLET;ORAL500MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
15955-388MetronidazoleMetronidazoleAlembic Labs LLCANDACurrent
15955-388MetronidazoleMetronidazoleORIT LABORATORIES LLCANDACurrent
15955-388MetronidazoleMetronidazoleAlembic Labs LLCANDACurrent
15955-388MetronidazoleMetronidazoleAlembic Labs LLCANDACurrent
15955-389MetronidazoleMetronidazoleAlembic Labs LLCANDACurrent
15955-389MetronidazoleMetronidazoleORIT LABORATORIES LLCANDACurrent
15955-389MetronidazoleMetronidazoleAlembic Labs LLCANDACurrent
15955-389MetronidazoleMetronidazoleAlembic Labs LLCANDACurrent