FDA.reportPublic FDA data

Application 210681

Type
ANDA
Sponsor
NOVITIUM PHARMA

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51407-097Ranitidine HydrochlorideRanitidine HydrochlorideGolden State Medical Supply Inc.ANDACurrent
51407-097Ranitidine HydrochlorideRanitidine HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-098Ranitidine HydrochlorideRanitidine HydrochlorideGolden State Medical Supply Inc.ANDACurrent
51407-098Ranitidine HydrochlorideRanitidine HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
70954-001Ranitidine HydrochlorideRanitidine HydrochlorideNovitium Pharma LLCANDACurrent
70954-001Ranitidine HydrochlorideRanitidine HydrochlorideNovitium Pharma LLCANDACurrent
70954-002Ranitidine HydrochlorideRanitidine HydrochlorideNovitium Pharma LLCANDACurrent
70954-002Ranitidine HydrochlorideRanitidine HydrochlorideNovitium Pharma LLCANDACurrent