FDA.reportPublic FDA data

Application 078542

Type
ANDA
Sponsor
GLENMARK PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RANITIDINE HYDROCHLORIDERANITIDINE HYDROCHLORIDETABLET;ORALEQ 150MG BASENoNo
002RANITIDINE HYDROCHLORIDERANITIDINE HYDROCHLORIDETABLET;ORALEQ 300MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-8021RanitidineRanitidineNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8021RanitidineRanitidineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
10544-438RanitidineRanitidineBlenheim Pharmacal, Inc.ANDACurrent
49999-043RanitidineRanitidineQuality Care Products, LLCANDACurrent
49999-043RanitidineRanitidineQuality Care Products, LLCANDACurrent
49999-428RanitidineRanitidineLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-428RanitidineRanitidineLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-428RanitidineRanitidineLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-428RanitidineRanitidineLake Erie Medical DBA Quality Care Products LLCANDACurrent
50090-1496RanitidineRanitidineA-S Medication SolutionsANDACurrent
50090-1496RanitidineRanitidineA-S Medication SolutionsANDACurrent
50090-1496RanitidineRanitidineA-S Medication SolutionsANDACurrent
50090-2574RanitidineRanitidineA-S Medication SolutionsANDACurrent
50090-2740RanitidineRanitidineA-S Medication SolutionsANDACurrent
50090-2740RanitidineRanitidineA-S Medication SolutionsANDACurrent
50436-6930RanitidineRanitidineUnit Dose ServicesANDACurrent
50436-6930RanitidineRanitidineUnit Dose ServicesANDACurrent
50436-6942RanitidineRanitidineUnit Dose ServicesANDACurrent
50436-6942RanitidineRanitidineUnit Dose ServicesANDACurrent
53002-5520RanitidineRanitidineRPK Pharmaceuticals, Inc.ANDACurrent
53217-372RanitidineRanitidineAidarex Pharmaceuticals LLCANDACurrent
60760-025RanitidineRanitidineSt. Mary's Medical Park PharmacyANDACurrent
60760-025RanitidineRanitidineSt. Mary's Medical Park PharmacyANDACurrent
60760-249RanitidineRanitidineSt. Mary's Medical Park PharmacyANDACurrent
60760-249RanitidineRanitidineSt. Mary's Medical Park PharmacyANDACurrent
61919-339RANITIDINERANITIDINEDIRECT RXANDACurrent
61919-339RANITIDINERANITIDINEDirect_RxANDACurrent
61919-339RANITIDINERANITIDINEDirect_RxANDACurrent
61919-455RANITIDINERANITIDINEDIRECT RXANDACurrent
61919-455RANITIDINERANITIDINEDirect_RxANDACurrent
61919-455RANITIDINERANITIDINEDirect_RxANDACurrent
63187-091RanitidineRanitidineProficient Rx LPANDACurrent
63187-091RanitidineRanitidineProficient Rx LPANDACurrent
63187-159RanitidineRanitidineProficient Rx LPANDACurrent
63187-159RanitidineRanitidineProficient Rx LPANDACurrent
63629-8216RanitidineRanitidineBryant Ranch PrepackANDACurrent
66267-188RanitidineRanitidineNuCare Pharmaceuticals, Inc.ANDACurrent
66267-188RanitidineRanitidineNuCare Pharmaceuticals, Inc.ANDACurrent
66267-452RanitidineRanitidineNuCare Pharmaceuticals, Inc.ANDACurrent
66267-452RanitidineRanitidineNuCare Pharmaceuticals, Inc.ANDACurrent
66267-734RanitidineRanitidineNuCare Pharmaceuticals, Inc.ANDACurrent
66267-734RanitidineRanitidineNuCare Pharmaceuticals, Inc.ANDACurrent
66267-815RanitidineRanitidineNuCare Pharmaceuticals, Inc.ANDACurrent
66267-815RanitidineRanitidineNuCare Pharmaceuticals, Inc.ANDACurrent
67046-648RanitidineRanitidineContract Pharmacy Services-PAANDACurrent
67046-649RanitidineRanitidineContract Pharmacy Services-PAANDACurrent
68071-2185RanitidineRanitidineNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2185RanitidineRanitidineNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3162RanitidineRanitidineNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3162RanitidineRanitidineNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3165RanitidineRanitidineNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3248RanitidineRanitidineNuCarePharmaceuticals, Inc.ANDACurrent
68071-3248RanitidineRanitidineNuCarePharmaceuticals, Inc.ANDACurrent
68071-3317RanitidineRanitidineNuCare Pharmaceuticals, Inc.ANDACurrent
68071-5015RanitidineRanitidineNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5015RanitidineRanitidineNuCare Pharmaceuticals,Inc.ANDACurrent
68462-248RanitidineRanitidineGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-248RanitidineRanitidineGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-249RanitidineRanitidineGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-249RanitidineRanitidineGlenmark Pharmaceuticals Inc., USAANDACurrent
68788-6382RanitidineRanitidinePreferred Pharmaceuticals Inc.ANDACurrent
68788-6382RanitidineRanitidinePreferred Pharmaceuticals Inc.ANDACurrent
68788-7388RanitidineRanitidinePreferred Pharmaceuticals Inc.ANDACurrent
68788-7388RanitidineRanitidinePreferred Pharmaceuticals Inc.ANDACurrent
68788-7388RanitidineRanitidinePreferred Pharmaceuticals Inc.ANDACurrent
70518-0801RanitidineRanitidineREMEDYREPACK INC.ANDACurrent
70518-0801RanitidineRanitidineREMEDYREPACK INC.ANDACurrent
70518-1361RanitidineRanitidineREMEDYREPACK INC.ANDACurrent
70518-1361RanitidineRanitidineREMEDYREPACK INC.ANDACurrent
70934-017RanitidineRanitidineDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-017RanitidineRanitidineDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-017RanitidineRanitidineDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-017RanitidineRanitidineDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-017RanitidineRanitidineDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-287RanitidineRanitidineDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71335-0342RanitidineRanitidineBryant Ranch PrepackANDACurrent
71335-0342RanitidineRanitidineBryant Ranch PrepackANDACurrent
71335-0363RanitidineRanitidineBryant Ranch PrepackANDACurrent
71335-0363RanitidineRanitidineBryant Ranch PrepackANDACurrent
71335-1327RanitidineRanitidineBryant Ranch PrepackANDACurrent