FDA.reportPublic FDA data

Application 076286

Type
ANDA
Sponsor
DR REDDYS LABS INC

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
0615-5574TizanidineTizanidineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-6564TizanidineTizanidineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
10544-890TizanidineTizanidineBlenheim Pharmacal, Inc.ANDACurrent
16714-171TizanidineTizanidineNorthStar Rx LLCANDACurrent
16714-172TizanidineTizanidineNorthStar Rx LLCANDACurrent
33261-103TizanidineTizanidineAidarex Pharmaceuticals LLCANDACurrent
33261-104TizanidineTizanidineAidarex Pharmaceuticals LLCANDACurrent
35356-662TizanidineTizanidineQuality Care Products, LLCANDACurrent
35356-662TizanidineTizanidineQuality Care Products, LLCANDACurrent
35356-662TizanidineTizanidineQuality Care Products, LLCANDACurrent
43063-455TizanidineTizanidinePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-455TizanidineTizanidinePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-455TizanidineTizanidinePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-455TizanidineTizanidinePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-455TizanidineTizanidinePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-455TizanidineTizanidinePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-455TizanidineTizanidinePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-455TizanidineTizanidinePD-Rx Pharmaceuticals, InANDACurrent
45865-348TizanidineTizanidineMedsource PharmaceuticalsANDACurrent
45865-386TizanidineTizanidineMedsource PharmaceuticalsANDACurrent
49999-347Tizanidine HydrochlorideTizanidine HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-347Tizanidine HydrochlorideTizanidine HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-347Tizanidine HydrochlorideTizanidine HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-347Tizanidine HydrochlorideTizanidine HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
50090-0811TizanidineTizanidineA-S Medication SolutionsANDACurrent
50090-0811TizanidineTizanidineA-S Medication SolutionsANDACurrent
50090-0811TizanidineTizanidineA-S Medication SolutionsANDACurrent
50090-0811TizanidineTizanidineA-S Medication SolutionsANDACurrent
50090-0811TizanidineTizanidineA-S Medication SolutionsANDACurrent
50090-0840TizanidineTizanidineA-S Medication SolutionsANDACurrent
50090-0840TizanidineTizanidineA-S Medication SolutionsANDACurrent
50090-0840TizanidineTizanidineA-S Medication SolutionsANDACurrent
50268-759TizanidineTizanidineAvPAKANDACurrent
50268-759TizanidineTizanidineAvPAKANDACurrent
50268-760TizanidineTizanidineAvPAKANDACurrent
50268-760TizanidineTizanidineAvPAKANDACurrent
50436-1180TizanidineTizanidineUnit Dose ServicesANDACurrent
50436-6755TizanidineTizanidineUnit Dose ServicesANDACurrent
50436-6756TizanidineTizanidineUnit Dose ServicesANDACurrent
52959-689TizanidineTizanidineH.J. Harkins Company, Inc.ANDACurrent
52959-691TizanidineTizanidineH.J. Harkins Company, Inc.ANDACurrent
55111-179TizanidineTizanidineDr. Reddy's Laboratories LimitedANDACurrent
55111-179TizanidineTizanidineDr. Reddy's Laboratories LimitedANDACurrent
55111-180TizanidineTizanidineDr. Reddy's Laboratories LimitedANDACurrent
55111-180TizanidineTizanidineDr. Reddy's Laboratories LimitedANDACurrent
60760-505TizanidineTizanidineSt. Mary's Medical Park PharmacyANDACurrent
60760-505TizanidineTizanidineSt. Mary's Medical Park PharmacyANDACurrent
60760-505TizanidineTizanidineSt. Mary's Medical Park PharmacyANDACurrent
60760-505TizanidineTizanidineSt. Mary's Medical Park PharmacyANDACurrent
60760-694TizanidineTizanidineSt. Mary's Medical Park PharmacyANDACurrent
60760-694TizanidineTizanidineSt Mary's Medical Park PharmacyANDACurrent
63187-009TizanidineTizanidineProficient Rx LPANDACurrent
63187-009TizanidineTizanidineProficient Rx LPANDACurrent
63187-009TizanidineTizanidineProficient Rx LPANDACurrent
63629-1673TizanidineTizanidineBryant Ranch PrepackANDACurrent
63629-1673TizanidineTizanidineBryant Ranch PrepackANDACurrent
63629-3209TizanidineTizanidineBryant Ranch PrepackANDACurrent
63629-3209TizanidineTizanidineBryant Ranch PrepackANDACurrent
63874-087TizanidineTizanidineAltura Pharmaceuticals, Inc.ANDACurrent
66336-843TizanidineTizanidineDispensing Solutions, Inc.ANDACurrent
67296-1417TizanidineTizanidineRedPharm Drug, Inc.ANDACurrent
68071-5268TizanidineTizanidineNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5268TizanidineTizanidineNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5268TizanidineTizanidineNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5268TizanidineTizanidineNuCare Pharmaceuticals,Inc.ANDACurrent
68084-645TizanidineTizanidineAmerican Health PackagingANDACurrent
68084-645TizanidineTizanidineAmerican Health PackagingANDACurrent
68084-645TizanidineTizanidineAmerican Health PackagingANDACurrent
68084-775TizanidineTizanidineAmerican Health PackagingANDACurrent
68084-775TizanidineTizanidineAmerican Health PackagingANDACurrent
68084-775TizanidineTizanidineAmerican Health PackagingANDACurrent
68788-7781TizanidineTizanidinePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7781TizanidineTizanidinePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7781TizanidineTizanidinePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7991TizanidineTizanidinePreferred Pharmaceuticals Inc.ANDACurrent
68788-7991TizanidineTizanidinePreferred Pharmaceuticals Inc.ANDACurrent
68788-9091TizanidineTizanidinePreferred Pharmaceuticals, IncANDACurrent
68788-9092TizanidineTizanidinePreferred Pharmaceuticals, IncANDACurrent
70518-0133TizanidineTizanidineREMEDYREPACK INC.ANDACurrent
70518-0133TizanidineTizanidineREMEDYREPACK INC.ANDACurrent