FDA.reportPublic FDA data

Application 074467

Type
ANDA
Sponsor
SANDOZ

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
0781-1883Ranitidine HydrochlorideRanitidine HydrochlorideSandoz IncANDACurrent
0781-1884Ranitidine HydrochlorideRanitidine HydrochlorideSandoz IncANDACurrent
51079-879Ranitidine HydrochlorideRanitidine HydrochlorideMylan Institutional Inc.ANDACurrent
53808-0776Ranitidine HydrochlorideRanitidine HydrochlorideState of Florida DOH Central PharmacyANDACurrent
68387-310Ranitidine HydrochlorideRanitidine HydrochlorideKeltman Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
42846ORIG2005-07-22
22338ORIG2003-08-01