Application 040847

Type
ANDA
Sponsor
DR REDDYS LABS LTD

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
55111-648GlycopyrrolateGlycopyrrolateDr. Reddy's Laboratories LimitedANDACurrent
55111-649GlycopyrrolateGlycopyrrolateDr. Reddy's Laboratories LimitedANDACurrent
68151-0614GlycopyrrolateGlycopyrrolateCarilion Materials ManagementANDACurrent