FDA.report

Application 205689

Type
ANDA
Sponsor
SUN PHARM

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001GUANFACINE HYDROCHLORIDEGUANFACINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 1MG BASENoNo
002GUANFACINE HYDROCHLORIDEGUANFACINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 2MG BASENoNo
003GUANFACINE HYDROCHLORIDEGUANFACINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 3MG BASENoNo
004GUANFACINE HYDROCHLORIDEGUANFACINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 4MG BASENoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-190GuanfacineGuanfacineNORTHSTAR RXLLCANDACurrent
16714-190GuanfacineGuanfacineNORTHSTAR RXLLCANDACurrent
16714-191GuanfacineGuanfacineNORTHSTAR RXLLCANDACurrent
16714-191GuanfacineGuanfacineNORTHSTAR RXLLCANDACurrent
16714-192GuanfacineGuanfacineNORTHSTAR RXLLCANDACurrent
16714-192GuanfacineGuanfacineNORTHSTAR RXLLCANDACurrent
16714-193GuanfacineGuanfacineNORTHSTAR RXLLCANDACurrent
16714-193GuanfacineGuanfacineNORTHSTAR RXLLCANDACurrent
63304-924GuanfacineGuanfacineSun Pharmaceutical Industries, IncANDACurrent
63304-924GuanfacineGuanfacineSun Pharmaceutical Industries, IncANDACurrent
63304-924GuanfacineGuanfacineSun Pharmaceutical Industries, IncANDACurrent
63304-924GuanfacineGuanfacineSun Pharmaceutical Industries, IncANDACurrent
63304-924GuanfacineGuanfacineSun Pharmaceutical Industries, IncANDACurrent
63304-924GuanfacineGuanfacineSun Pharmaceutical Industries, IncANDACurrent
63304-925GuanfacineGuanfacineSun Pharmaceutical Industries, IncANDACurrent
63304-925GuanfacineGuanfacineSun Pharmaceutical Industries, IncANDACurrent
63304-925GuanfacineGuanfacineSun Pharmaceutical Industries, IncANDACurrent
63304-925GuanfacineGuanfacineSun Pharmaceutical Industries, IncANDACurrent
63304-925GuanfacineGuanfacineSun Pharmaceutical Industries, IncANDACurrent
63304-925GuanfacineGuanfacineSun Pharmaceutical Industries, IncANDACurrent
63304-926GuanfacineGuanfacineSun Pharmaceutical Industries, IncANDACurrent
63304-926GuanfacineGuanfacineSun Pharmaceutical Industries, IncANDACurrent
63304-926GuanfacineGuanfacineSun Pharmaceutical Industries, IncANDACurrent
63304-926GuanfacineGuanfacineSun Pharmaceutical Industries, IncANDACurrent
63304-926GuanfacineGuanfacineSun Pharmaceutical Industries, IncANDACurrent
63304-926GuanfacineGuanfacineSun Pharmaceutical Industries, IncANDACurrent
63304-927GuanfacineGuanfacineSun Pharmaceutical Industries, IncANDACurrent
63304-927GuanfacineGuanfacineSun Pharmaceutical Industries, IncANDACurrent
63304-927GuanfacineGuanfacineSun Pharmaceutical Industries, IncANDACurrent
63304-927GuanfacineGuanfacineSun Pharmaceutical Industries, IncANDACurrent
63304-927GuanfacineGuanfacineSun Pharmaceutical Industries, IncANDACurrent
63304-927GuanfacineGuanfacineSun Pharmaceutical Industries, IncANDACurrent
63629-1102GuanfacineGuanfacineBryant Ranch PrepackANDACurrent
63629-1102GuanfacineGuanfacineBryant Ranch PrepackANDACurrent
63629-1102GuanfacineGuanfacineBryant Ranch PrepackANDACurrent
63629-1103GuanfacineGuanfacineBryant Ranch PrepackANDACurrent
63629-1103GuanfacineGuanfacineBryant Ranch PrepackANDACurrent
63629-1103GuanfacineGuanfacineBryant Ranch PrepackANDACurrent
63629-1104GuanfacineGuanfacineBryant Ranch PrepackANDACurrent
63629-1104GuanfacineGuanfacineBryant Ranch PrepackANDACurrent
63629-1104GuanfacineGuanfacineBryant Ranch PrepackANDACurrent
63629-1105GuanfacineGuanfacineBryant Ranch PrepackANDACurrent
63629-1105GuanfacineGuanfacineBryant Ranch PrepackANDACurrent
63629-1105GuanfacineGuanfacineBryant Ranch PrepackANDACurrent
63629-1105GuanfacineGuanfacineBryant Ranch PrepackANDACurrent
63629-8161GuanfacineGuanfacineBryant Ranch PrepackANDACurrent
63629-8161GuanfacineGuanfacineBryant Ranch PrepackANDACurrent
63629-8203GuanfacineGuanfacineBryant Ranch PrepackANDACurrent
63629-8203GuanfacineGuanfacineBryant Ranch PrepackANDACurrent