FDA.report

Application 076533

Type
ANDA
Sponsor
APOTEX

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDETABLET;ORALEQ 2MG BASENoNo
002TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDETABLET;ORALEQ 4MG BASENoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-6418tizanidinetizanidineMajor PharmaceuticalsANDACurrent
0904-6418tizanidinetizanidineMajor PharmaceuticalsANDACurrent
0904-6418tizanidinetizanidineMajor PharmaceuticalsANDACurrent
0904-6418tizanidinetizanidineMajor PharmaceuticalsANDACurrent
10544-576tizanidinetizanidineBlenheim Pharmacal, Inc.ANDACurrent
10544-587tizanidinetizanidineBlenheim Pharmacal, Inc.ANDACurrent
10544-863tizanidinetizanidineBlenheim Pharmacal, Inc.ANDACurrent
43353-167tizanidinetizanidineAphena Pharma Solutions - Tennessee, LLCANDACurrent
50090-0813tizanidinetizanidineA-S Medication SolutionsANDACurrent
50090-0813tizanidinetizanidineA-S Medication SolutionsANDACurrent
50090-0841tizanidinetizanidineA-S Medication SolutionsANDACurrent
50090-0841tizanidinetizanidineA-S Medication SolutionsANDACurrent
50436-0251tizanidinetizanidineUnit Dose ServicesANDACurrent
50436-0252tizanidinetizanidineUnit Dose ServicesANDACurrent
55154-7287tizanidinetizanidineCardinal Health 107, LLCANDACurrent
55154-7287tizanidinetizanidineCardinal HealthANDACurrent
60429-241tizanidinetizanidineGolden State Medical Supply, Inc.ANDACurrent
60429-241tizanidinetizanidineGolden State Medical Supply, Inc.ANDACurrent
60429-241tizanidinetizanidineGolden State Medical Supply, Inc.ANDACurrent
60429-242tizanidinetizanidineGolden State Medical Supply, Inc.ANDACurrent
60429-242tizanidinetizanidineGolden State Medical Supply, Inc.ANDACurrent
60429-242tizanidinetizanidineGolden State Medical Supply, Inc.ANDACurrent
60505-0251tizanidinetizanidineApotex Corp.ANDACurrent
60505-0251tizanidinetizanidineApotex Corp.ANDACurrent
60505-0252tizanidinetizanidineApotex Corp.ANDACurrent
60505-0252tizanidinetizanidineApotex Corp.ANDACurrent
60760-253tizanidinetizanidineSt. Mary's Medical Park PharmacyANDACurrent
60760-253tizanidinetizanidineSt. Mary's Medical Park PharmacyANDACurrent
60760-503tizanidinetizanidineSt. Mary's Medical Park PharmacyANDACurrent
61919-220TIZANIDINETIZANIDINEDirect RxANDACurrent
61919-221TIZANIDINETIZANIDINEDirect_RxANDACurrent
61919-221TIZANIDINETIZANIDINEDirect_RxANDACurrent
61919-221TIZANIDINETIZANIDINEDirect_RxANDACurrent
61919-221TIZANIDINETIZANIDINEDirect RxANDACurrent
61919-221TIZANIDINETIZANIDINEDirect_RxANDACurrent
61919-221TIZANIDINETIZANIDINEDirect_RxANDACurrent
61919-221TIZANIDINETIZANIDINEDirect_RxANDACurrent
61919-221TIZANIDINETIZANIDINEDirect_RxANDACurrent
61919-221TIZANIDINETIZANIDINEDirect_RxANDACurrent
61919-221TIZANIDINETIZANIDINEDirect_RxANDACurrent
63187-145tizanidinetizanidineProficient Rx LPANDACurrent
63187-145tizanidinetizanidineProficient Rx LPANDACurrent
63187-145tizanidinetizanidineProficient Rx LPANDACurrent
63629-6432tizanidinetizanidineBryant Ranch PrepackANDACurrent
63629-6432tizanidinetizanidineBryant Ranch PrepackANDACurrent
66267-598tizanidinetizanidineNuCare Pharmaceuticals, Inc.ANDACurrent
66267-598tizanidinetizanidineNuCare Pharmaceuticals, Inc.ANDACurrent
67296-1599tizanidinetizanidineRedPharm Drug, Inc.ANDACurrent
67296-1599tizanidinetizanidineRedPharm Drug, Inc.ANDACurrent
67296-1599tizanidinetizanidineRedPharm Drug, Inc.ANDACurrent
68071-3288tizanidinetizanidineNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3288tizanidinetizanidineNuCare Pharmaceuticals, Inc.ANDACurrent
68788-9497tizanidinetizanidinePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9497tizanidinetizanidinePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9497tizanidinetizanidinePreferred PharmaceuticalsANDACurrent
68788-9497tizanidinetizanidinePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9514tizanidinetizanidinePreferred PharmaceuticalsANDACurrent
68788-9514tizanidinetizanidinePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9514tizanidinetizanidinePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9514tizanidinetizanidinePreferred Pharmaceuticals, Inc.ANDACurrent
70518-0774tizanidinetizanidineREMEDYREPACK INC.ANDACurrent
70518-0774tizanidinetizanidineREMEDYREPACK INC.ANDACurrent
70518-0774tizanidinetizanidineREMEDYREPACK INC.ANDACurrent
70934-021tizanidinetizanidineDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71335-0003tizanidinetizanidineBryant Ranch PrepackANDACurrent
71335-0003tizanidinetizanidineBryant Ranch PrepackANDACurrent
71335-0737tizanidinetizanidineBryant Ranch PrepackANDACurrent
71335-0737tizanidinetizanidineBryant Ranch PrepackANDACurrent
71610-162tizanidinetizanidineAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-355tizanidinetizanidineAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-355tizanidinetizanidineAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-455tizanidinetizanidineAphena Pharma Solutions - Tennessee, LLCANDACurrent