FDA.reportPublic FDA data

Application 215932

Type
ANDA
Sponsor
DR REDDYS LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GUAIFENESINGUAIFENESINTABLET, EXTENDED RELEASE;ORAL600MGNoNo
002GUAIFENESINGUAIFENESINTABLET, EXTENDED RELEASE;ORAL1.2GMNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43598-008Guaifenesin 600 mgGuaifenesinDr. ReddyANDACurrent
43598-009Guaifenesin 1200 mgGuaifenesinDr. ReddyANDACurrent
43598-108Guaifenesin 1200 mgGuaifenesinDr. Reddy's Laboratories Inc.ANDACurrent
43598-110Guaifenesin 600 mgGuaifenesinDr. Reddy's Laboratories Inc.ANDACurrent
51316-008Guaifenesin 600 mgGuaifenesinCVS PharmacyANDACurrent
51316-008Guaifenesin 600 mgGuaifenesinCVS PharmacyANDACurrent