FDA.reportPublic FDA data

Application 075109

Type
ANDA
Sponsor
AMNEAL PHARM

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
17856-0711Guanfacine HydrochlorideGuanfacineAtlantic Biologicals CorpsANDACurrent
42291-310Guanfacine HydrochlorideGuanfacine HydrochlorideAvKARE, Inc.ANDACurrent
42291-310Guanfacine HydrochlorideGuanfacine HydrochlorideAvKARE, Inc.ANDACurrent
42291-310Guanfacine HydrochlorideGuanfacine HydrochlorideAvKAREANDACurrent
42291-310Guanfacine HydrochlorideGuanfacine HydrochlorideAvKAREANDACurrent
42291-311Guanfacine HydrochlorideGuanfacine HydrochlorideAvKARE, Inc.ANDACurrent
50090-4119Guanfacine HydrochlorideGuanfacineA-S Medication SolutionsANDACurrent
50090-4119Guanfacine HydrochlorideGuanfacineA-S Medication SolutionsANDACurrent
50090-6073Guanfacine HydrochlorideGuanfacineA-S Medication SolutionsANDACurrent
50268-373Guanfacine HydrochlorideGuanfacineAvPAKANDACurrent
50268-374Guanfacine HydrochlorideGuanfacineAvPAKANDACurrent
50268-374Guanfacine HydrochlorideGuanfacineAvPAKANDACurrent
50268-374Guanfacine HydrochlorideGuanfacineAvPAKANDACurrent
50268-374Guanfacine HydrochlorideGuanfacineAvPAKANDACurrent
53746-711Guanfacine HydrochlorideGuanfacineAmneal Pharmaceuticals of New York LLCANDACurrent
53746-713Guanfacine HydrochlorideGuanfacineAmneal Pharmaceuticals of New York LLCANDACurrent
64725-0711Guanfacine HydrochlorideGuanfacine HydrochlorideTYA PharmaceuticalsANDACurrent
65162-711Guanfacine HydrochlorideGuanfacineAmneal Pharmaceuticals LLCANDACurrent
65162-711Guanfacine HydrochlorideGuanfacineAmneal Pharmaceuticals LLCANDACurrent
65162-711Guanfacine HydrochlorideGuanfacineAmneal Pharmaceuticals LLCANDACurrent
65162-711Guanfacine HydrochlorideGuanfacineAmneal Pharmaceuticals LLCANDACurrent
65162-713Guanfacine HydrochlorideGuanfacineAmneal Pharmaceuticals LLCANDACurrent
65162-713Guanfacine HydrochlorideGuanfacineAmneal Pharmaceuticals LLCANDACurrent
65162-713Guanfacine HydrochlorideGuanfacineAmneal Pharmaceuticals LLCANDACurrent
65162-713Guanfacine HydrochlorideGuanfacineAmneal Pharmaceuticals LLCANDACurrent
68084-748Guanfacine HydrochlorideGuanfacine HydrochlorideAmerican Health PackagingANDACurrent
68084-748Guanfacine HydrochlorideGuanfacine HydrochlorideAmerican Health PackagingANDACurrent
68084-748Guanfacine HydrochlorideGuanfacine HydrochlorideAmerican Health PackagingANDACurrent
68084-748Guanfacine HydrochlorideGuanfacine HydrochlorideAmerican Health PackagingANDACurrent
68094-019GuanfacineguanfacinePrecision Dose, Inc.ANDACurrent
70518-0793Guanfacine HydrochlorideGuanfacineREMEDYREPACK INC.ANDACurrent
70518-0793Guanfacine HydrochlorideGuanfacineREMEDYREPACK INC.ANDACurrent
70518-0793Guanfacine HydrochlorideGuanfacineREMEDYREPACK INC.ANDACurrent
70518-0793Guanfacine HydrochlorideGuanfacineREMEDYREPACK INC.ANDACurrent