FDA.reportPublic FDA data

Application 091283

Type
ANDA
Sponsor
UNICHEM LABS LTD

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-7996TizanidineTizanidineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
29300-168TizanidineTizanidineUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-168TizanidineTizanidineUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-168TizanidineTizanidineUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-168TizanidineTizanidineUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-169TizanidineTizanidineUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-169TizanidineTizanidineUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-169TizanidineTizanidineUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-169TizanidineTizanidineUnichem Pharmaceuticals (USA), Inc.ANDACurrent
43063-868TizanidineTizanidinePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-868TizanidineTizanidinePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-868TizanidineTizanidinePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-868TizanidineTizanidinePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-868TizanidineTizanidinePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-868TizanidineTizanidinePD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-2078TizanidineTizanidineA-S Medication SolutionsANDACurrent
50090-2078TizanidineTizanidineA-S Medication SolutionsANDACurrent
50090-5767TizanidineTizanidineA-S Medication SolutionsANDACurrent
50090-5767TizanidineTizanidineA-S Medication SolutionsANDACurrent
51655-741Tizanidine HClTizanidine HClNorthwind PharmaceuticalsANDACurrent
53002-1418TizanidineTizanidineRPK Pharmaceuticals, Inc.ANDACurrent
53217-344TizanidineTizanidineAidarex Pharmaceuticals LLCANDACurrent
55700-287TizanidineTizanidineLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-287TizanidineTizanidineLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-288TizanidineTizanidineLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-288TizanidineTizanidineLake Erie Medical DBA Quality Care Products LLCANDACurrent
60760-263TizanidineTizanidineSt. Mary's Medical Park PharmacyANDACurrent
60760-263TizanidineTizanidineSt. Mary's Medical Park PharmacyANDACurrent
60760-263TizanidineTizanidineSt. Mary's Medical Park PharmacyANDACurrent
60760-782TizanidineTizanidineSt. Mary's Medical Park PharmacyANDACurrent
60760-782TizanidineTizanidineSt. Mary's Medical Park PharmacyANDACurrent
60760-782TizanidineTizanidineSt. Mary's Medical Park PharmacyANDACurrent
60760-782TizanidineTizanidineSt. Mary's Medical Park PharmacyANDACurrent
60760-782TizanidineTizanidineSt. Mary's Medical Park PharmacyANDACurrent
61919-196TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDEANDACurrent
61919-196TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDEANDACurrent
61919-196TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDEANDACurrent
61919-811TIZANDINETIZANDINEDIRECT RXANDACurrent
61919-811TIZANDINETIZANDINEDirect_RxANDACurrent
61919-811TIZANDINETIZANDINEDirect_RxANDACurrent
61919-811TIZANDINETIZANDINEDirect_RxANDACurrent
61919-811TIZANDINETIZANDINEDirect_RxANDACurrent
61919-811TIZANDINETIZANDINEDirect_RxANDACurrent
61919-811TIZANDINETIZANDINEDirect_RxANDACurrent
61919-811TIZANDINETIZANDINEDirectRXANDACurrent
61919-811TIZANDINETIZANDINEDIRECT RXANDACurrent
63187-493TizanidineTizanidineProficient Rx LPANDACurrent
63187-493TizanidineTizanidineProficient Rx LPANDACurrent
63187-493TizanidineTizanidineProficient Rx LPANDACurrent
63187-910TizanidineTizanidineProficient Rx LPANDACurrent
63187-910TizanidineTizanidineProficient Rx LPANDACurrent
63187-910TizanidineTizanidineProficient Rx LPANDACurrent
63187-910TizanidineTizanidineProficient Rx LPANDACurrent
67296-1192TizanidineTizanidineRedPharm Drug, Inc.ANDACurrent
67296-1192TizanidineTizanidineRedPharm Drug, Inc.ANDACurrent
67296-1567TizanidineTizanidineRedPharm Drug, Inc.ANDACurrent
67296-1567TizanidineTizanidineRedPharm Drug, Inc.ANDACurrent
68071-4463TizanidineTizanidineNuCare Pharmaceuticals,InANDACurrent
68071-4463TizanidineTizanidineNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4463TizanidineTizanidineNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7782TizanidineTizanidinePreferred Pharmaceuticals Inc.ANDACurrent
68788-7782TizanidineTizanidinePreferred Pharmaceuticals Inc.ANDACurrent
68788-7782TizanidineTizanidinePreferred Pharmaceuticals Inc.ANDACurrent
70518-1598TizanidineTizanidineREMEDYREPACK INC.ANDACurrent
70518-1598TizanidineTizanidineREMEDYREPACK INC.ANDACurrent
70518-1598TizanidineTizanidineREMEDYREPACK INC.ANDACurrent
70518-1598TizanidineTizanidineREMEDYREPACK INC.ANDACurrent
70518-1598TizanidineTizanidineREMEDYREPACK INC.ANDACurrent
70518-2210TizanidineTizanidineREMEDYREPACK INC.ANDACurrent
70518-2210TizanidineTizanidineREMEDYREPACK INC.ANDACurrent
70518-2210TizanidineTizanidineREMEDYREPACK INC.ANDACurrent
70518-2210TizanidineTizanidineREMEDYREPACK INC.ANDACurrent
70518-2210TizanidineTizanidineREMEDYREPACK INC.ANDACurrent
70934-656TizanidineTizanidineDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
71335-0424TizanidineTizanidineBryant Ranch PrepackANDACurrent
71335-0424TizanidineTizanidineBryant Ranch PrepackANDACurrent
71335-0914TizanidineTizanidineBryant Ranch PrepackANDACurrent
71335-0914TizanidineTizanidineBryant Ranch PrepackANDACurrent
71610-228TizanidineTizanidineAphena Pharma Solutions - Tennessee, LLCANDACurrent
80175-0169TIZANIDINETizanidineCentral PackagingANDACurrent