FDA.reportPublic FDA data

Application 074673

Type
ANDA
Sponsor
EPIC PHARMA LLC

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
0904-7140GuanfacineGuanfacineMajor PharmaceuticalsANDACurrent
24658-730GuanfacineGuanfacinePuraCap Laboratories LLC dba Blu PharmaceuticalsANDACurrent
24658-731GuanfacineGuanfacinePuraCap Laboratories LLC dba Blu PharmaceuticalsANDACurrent
42806-048GuanfacineGuanfacineEpic Pharma, LLCANDACurrent
42806-048GuanfacineGuanfacineEpic Pharma, LLCANDACurrent
42806-296GuanfacineGuanfacineEpic Pharma, LLCANDACurrent
63187-302GuanfacineGuanfacineProficient Rx LPANDACurrent
63187-302GuanfacineGuanfacineProficient Rx LPANDACurrent