FDA.reportPublic FDA data

Application 214689

Type
ANDA
Sponsor
UNICHEM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GUANFACINE HYDROCHLORIDEGUANFACINE HYDROCHLORIDETABLET;ORALEQ 1MG BASENoNo
002GUANFACINE HYDROCHLORIDEGUANFACINE HYDROCHLORIDETABLET;ORALEQ 2MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
29300-458Guanfacine HydrochlorideGuanfacine HydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-458Guanfacine HydrochlorideGuanfacine HydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-459Guanfacine HydrochlorideGuanfacine HydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-459Guanfacine HydrochlorideGuanfacine HydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
60687-710Guanfacine HydrochlorideGuanfacine HydrochlorideAmerican Health PackagingANDACurrent
68071-2719Guanfacine HydrochlorideGuanfacine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
70518-3516Guanfacine HydrochlorideGuanfacine HydrochlorideREMEDYREPACK INC.ANDACurrent