FDA.reportPublic FDA data

Application 078868

Type
ANDA
Sponsor
APOTEX INC

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
42291-810Tizanidine HydrochlorideTizanidine HydrochlorideAvKARE, Inc.ANDACurrent
42291-810Tizanidine HydrochlorideTizanidine HydrochlorideAvKARE, Inc.ANDACurrent
42291-810Tizanidine HydrochlorideTizanidine HydrochlorideAvKARE, Inc.ANDACurrent
42291-811Tizanidine HydrochlorideTizanidine HydrochlorideAvKARE, Inc.ANDACurrent
42291-811Tizanidine HydrochlorideTizanidine HydrochlorideAvKARE, Inc.ANDACurrent
42291-811Tizanidine HydrochlorideTizanidine HydrochlorideAvKARE, Inc.ANDACurrent
42291-812Tizanidine HydrochlorideTizanidine HydrochlorideAvKARE, Inc.ANDACurrent
42291-812Tizanidine HydrochlorideTizanidine HydrochlorideAvKARE, Inc.ANDACurrent
42291-812Tizanidine HydrochlorideTizanidine HydrochlorideAvKARE, Inc.ANDACurrent
45865-954Tizanidine HydrochlorideTizanidine Hydrochloridemedsource pharmaceuticalsANDACurrent
55700-789Tizanidine HydrochlorideTizanidine HydrochlorideQuality Care Products, LLCANDACurrent
55700-789Tizanidine HydrochlorideTizanidine HydrochlorideQuality Care Products, LLCANDACurrent
60505-2648Tizanidine HydrochlorideTizanidine HydrochlorideApotex Corp.ANDACurrent
60505-2648Tizanidine HydrochlorideTizanidine HydrochlorideApotex Corp.ANDACurrent
60505-2648Tizanidine HydrochlorideTizanidine HydrochlorideApotex Corp.ANDACurrent
60505-2649Tizanidine HydrochlorideTizanidine HydrochlorideApotex Corp.ANDACurrent
60505-2649Tizanidine HydrochlorideTizanidine HydrochlorideApotex Corp.ANDACurrent
60505-2649Tizanidine HydrochlorideTizanidine HydrochlorideApotex Corp.ANDACurrent
60505-2650Tizanidine HydrochlorideTizanidine HydrochlorideApotex Corp.ANDACurrent
60505-2650Tizanidine HydrochlorideTizanidine HydrochlorideApotex Corp.ANDACurrent
60505-2650Tizanidine HydrochlorideTizanidine HydrochlorideApotex Corp.ANDACurrent
71335-0317Tizanidine HydrochlorideTizanidine HydrochlorideBryant Ranch PrepackANDACurrent
71335-0317Tizanidine HydrochlorideTizanidine HydrochlorideBryant Ranch PrepackANDACurrent
71335-0317Tizanidine HydrochlorideTizanidine HydrochlorideBryant Ranch PrepackANDACurrent
71335-0317Tizanidine HydrochlorideTizanidine HydrochlorideBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9192ORIG2012-02-10