FDA.reportPublic FDA data

Application 077824

Type
ANDA
Sponsor
AMNEAL PHARMS NY

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
0440-8300RanitidineRanitidineLiberty Pharmaceuticals, Inc.ANDACurrent
0440-8305RanitidineRanitidineLiberty Pharmaceuticals, Inc.ANDACurrent
10544-056RanitidineRanitidineBlenheim Pharmacal, Inc.ANDACurrent
10544-516RanitidineRanitidineBlenheim Pharmacal, Inc.ANDACurrent
21695-109RanitidineRanitidineRebel DistributorsANDACurrent
21695-110RanitidineRanitidineRebel DistributorsANDACurrent
33261-099RanitidineRanitidineAidarex Pharmaceuticals LLCANDACurrent
33261-202RanitidineRanitidineAidarex Pharmaceuticals LLCANDACurrent
33358-316RanitidineRanitidineRxChange Co.ANDACurrent
35356-670RanitidineRanitidineLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-809RanitidineRanitidineLake Erie Medical DBA Quality Care Products LLCANDACurrent
42291-724RanitidineRanitidineAvKARE, Inc.ANDACurrent
42291-724RanitidineRanitidineAvKARE, Inc.ANDACurrent
42291-724RanitidineRanitidineAvKAREANDACurrent
42291-725RanitidineRanitidineAvKARE, Inc.ANDACurrent
42291-725RanitidineRanitidineAvKARE, Inc.ANDACurrent
42708-049RanitidineRanitidineQPharma IncANDACurrent
42708-118RanitidineRanitidineQPharma IncANDACurrent
42708-118RanitidineRanitidineQPharma IncANDACurrent
43063-087RanitidineRanitidinePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-087RanitidineRanitidinePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-844RanitidineRanitidinePD-Rx Pharmaceuticals, InANDACurrent
43063-844RanitidineRanitidinePD-Rx Pharmaceuticals, Inc.ANDACurrent
43353-445RanitidineRanitidineAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-967RanitidineRanitidineAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-967RanitidineRanitidineAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-971RanitidineRanitidineAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-971RanitidineRanitidineAphena Pharma Solutions - Tennessee, LLCANDACurrent
45865-416RanitidineRanitidineMedsource PharmaceuticalsANDACurrent
45865-416RanitidineRanitidineMedsource PharmaceuticalsANDACurrent
50090-0604RanitidineRanitidineA-S Medication SolutionsANDACurrent
50090-0605RanitidineRanitidineA-S Medication SolutionsANDACurrent
50090-0606RanitidineRanitidineA-S Medication SolutionsANDACurrent
50436-0253RanitidineRanitidineUnit Dose ServicesANDACurrent
50436-0253RanitidineRanitidineUnit Dose ServicesANDACurrent
51655-681RANITIDINEranitidine hydrochlorideNorthwind Pharmaceuticals, LLCANDACurrent
53217-343RanitidineRanitidineAidarex Pharmaceuticals LLCANDACurrent
53746-253RanitidineRanitidineAmneal Pharmaceuticals of New York LLCANDACurrent
53746-253RanitidineRanitidineAmneal Pharmaceuticals of New York, LLCANDACurrent
53746-253RanitidineRanitidineAmneal Pharmaceuticals of New York LLCANDACurrent
53746-253RanitidineRanitidineAmneal Pharmaceuticals of New York LLCANDACurrent
53746-254RanitidineRanitidineAmneal Pharmaceuticals of New York LLCANDACurrent
53746-254RanitidineRanitidineAmneal Pharmaceuticals of New York, LLCANDACurrent
53746-254RanitidineRanitidineAmneal Pharmaceuticals of New York LLCANDACurrent
53746-254RanitidineRanitidineAmneal Pharmaceuticals of New York LLCANDACurrent
53808-0775RanitidineRanitidineState of Florida DOH Central PharmacyANDACurrent
55289-319RanitidineRanitidinePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-319RanitidineRanitidinePD-Rx Pharmaceuticals, Inc.ANDACurrent
60687-322RanitidineRanitidineAmerican Health PackagingANDACurrent
60687-322RanitidineRanitidineAmerican Health PackagingANDACurrent
60687-322RanitidineRanitidineAmerican Health PackagingANDACurrent
60760-026RANITIDINERANITIDINESt Marys Medical Park PharmacyANDACurrent
61919-199RANITIDINE HYDROCHLORIDERANITIDINE HYDROCHLORIDEDirect RxANDACurrent
61919-199RANITIDINE HYDROCHLORIDERANITIDINE HYDROCHLORIDEDirect RxANDACurrent
63187-686RanitidineRanitidineProficient Rx LPANDACurrent
63187-686RanitidineRanitidineProficient Rx LPANDACurrent
63629-1671RanitidineRanitidineBryant Ranch PrepackANDACurrent
63629-1671RanitidineRanitidineBryant Ranch PrepackANDACurrent
63629-6757RanitidineRanitidineBryant Ranch PrepackANDACurrent
63629-6757RanitidineRanitidineBryant Ranch PrepackANDACurrent
63629-7669RanitidineRanitidineBryant Ranch PrepackANDACurrent
63629-7669RanitidineRanitidineBryant Ranch PrepackANDACurrent
63629-7669RanitidineRanitidineBryant Ranch PrepackANDACurrent
63629-8236RanitidineRanitidineBryant Ranch PrepackANDACurrent
63629-8236RanitidineRanitidineBryant Ranch PrepackANDACurrent
63739-489RanitidineRanitidineMcKesson Corporation dba SKY PackagingANDACurrent
63739-489RanitidineRanitidineMcKesson CorporationANDACurrent
65162-253RanitidineRanitidineAmneal Pharmaceuticals LLCANDACurrent
65162-253RanitidineRanitidineAmneal Pharmaceuticals LLCANDACurrent
65162-253RanitidineRanitidineAmneal Pharmaceuticals LLCANDACurrent
65162-253RanitidineRanitidineAmneal Pharmaceuticals LLCANDACurrent
65162-254RanitidineRanitidineAmneal Pharmaceuticals LLCANDACurrent
65162-254RanitidineRanitidineAmneal Pharmaceuticals LLCANDACurrent
65162-254RanitidineRanitidineAmneal Pharmaceuticals LLCANDACurrent
65162-254RanitidineRanitidineAmneal Pharmaceuticals LLCANDACurrent
67046-651RanitidineRanitidineContract Pharmacy Services-PAANDACurrent
67046-652RanitidineRanitidineContract Pharmacy Services-PAANDACurrent
68071-2190RanitidineRanitidineNuCare Pharmaceuticals, Inc.ANDACurrent
68071-2190RanitidineRanitidineNuCare Pharmaceuticals, Inc.ANDACurrent
68151-1610RanitidineRanitidineCarilion Materials ManagementANDACurrent