FDA.reportPublic FDA data

Application 209605

Type
ANDA
Sponsor
JUBILANT GENERICS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDECAPSULE;ORALEQ 2MG BASENoNo
002TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDECAPSULE;ORALEQ 4MG BASENoNo
003TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDECAPSULE;ORALEQ 6MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55700-865Tizanidine HydrochlorideTizanidine HydrochlorideQuality Care Products, LLCANDACurrent
55700-865Tizanidine HydrochlorideTizanidine HydrochlorideQuality Care Products, LLCANDACurrent
59746-670Tizanidine HydrochlorideTizanidine HydrochlorideJubilant Cadista Pharmaceuticals Inc.ANDACurrent
59746-671Tizanidine HydrochlorideTizanidine HydrochlorideJubilant Cadista Pharmaceuticals Inc.ANDACurrent
59746-672Tizanidine HydrochlorideTizanidine HydrochlorideJubilant Cadista Pharmaceuticals Inc.ANDACurrent
69420-1502TizanidineTizanidine hydrochlorideSA3, LLCANDACurrent
69420-1502TizanidineTizanidine hydrochlorideSA3, LLCANDACurrent
69420-1504TizanidineTizanidine hydrochlorideSA3, LLCANDACurrent
69420-1504TizanidineTizanidine hydrochlorideSA3, LLCANDACurrent
69420-1506TizanidineTizanidine hydrochlorideSA3, LLCANDACurrent
69420-1506TizanidineTizanidine hydrochlorideSA3, LLCANDACurrent
71335-1698Tizanidine HydrochlorideTizanidine HydrochlorideBryant Ranch PrepackANDACurrent
71335-1698Tizanidine HydrochlorideTizanidine HydrochlorideBryant Ranch PrepackANDACurrent