FDA.reportPublic FDA data

Application 203657

Type
ANDA
Sponsor
ORIT LABS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GLYCOPYRROLATEGLYCOPYRROLATETABLET;ORAL1MGNoNo
002GLYCOPYRROLATEGLYCOPYRROLATETABLET;ORAL2MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
15955-305GLYCOPYRROLATEGLYCOPYRROLATEORIT LABORATORIES LLCANDACurrent
15955-305GLYCOPYRROLATEGLYCOPYRROLATEAlembic Labs LLCANDACurrent
15955-305GLYCOPYRROLATEGLYCOPYRROLATEORIT LABORATORIES LLCANDACurrent
15955-318GLYCOPYRROLATEGLYCOPYRROLATEORIT LABORATORIES LLCANDACurrent
15955-318GLYCOPYRROLATEGLYCOPYRROLATEAlembic Labs LLCANDACurrent
15955-318GLYCOPYRROLATEGLYCOPYRROLATEORIT LABORATORIES LLCANDACurrent