FDA.reportPublic FDA data

Application 202601

Type
ANDA
Sponsor
ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLONIDINE HYDROCHLORIDECLONIDINE HYDROCHLORIDEINJECTABLE;INJECTION1MG/10ML (0.1MG/ML)NoNo
002CLONIDINE HYDROCHLORIDECLONIDINE HYDROCHLORIDEINJECTABLE;INJECTION5MG/10ML (0.5MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68382-601clonidine hydrochlorideclonidine hydrochlorideZydus Pharmaceuticals USA Inc.ANDACurrent
68382-601clonidine hydrochlorideclonidine hydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-601clonidine hydrochlorideclonidine hydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-602clonidine hydrochlorideclonidine hydrochlorideZydus Pharmaceuticals USA Inc.ANDACurrent
68382-602clonidine hydrochlorideclonidine hydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-602clonidine hydrochlorideclonidine hydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
70771-1193clonidine hydrochlorideclonidine hydrochlorideCadila Healthcare LimitedANDACurrent
70771-1193clonidine hydrochlorideclonidine hydrochlorideZydus Lifesciences LimitedANDACurrent
70771-1193clonidine hydrochlorideclonidine hydrochlorideCadila Healthcare LimitedANDACurrent
70771-1193clonidine hydrochlorideclonidine hydrochlorideCadila Healthcare LimitedANDACurrent
70771-1194clonidine hydrochlorideclonidine hydrochlorideCadila Healthcare LimitedANDACurrent
70771-1194clonidine hydrochlorideclonidine hydrochlorideZydus Lifesciences LimitedANDACurrent
70771-1194clonidine hydrochlorideclonidine hydrochlorideCadila Healthcare LimitedANDACurrent
70771-1194clonidine hydrochlorideclonidine hydrochlorideCadila Healthcare LimitedANDACurrent