FDA.reportPublic FDA data

Application 079057

Type
ANDA
Sponsor
SUN PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALFUZOSIN HYDROCHLORIDEALFUZOSIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
33261-994Alfuzosin HydrochlorideAlfuzosin HydrochlorideAidarex Pharmaceuticals LLCANDACurrent
47335-956Alfuzosin HydrochlorideAlfuzosin HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
47335-956Alfuzosin HydrochlorideAlfuzosin HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
47335-956Alfuzosin HydrochlorideAlfuzosin HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
47335-956Alfuzosin HydrochlorideAlfuzosin HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
61919-349ALFUZOSIN HYDROCHLORIDEALFUZOSIN HYDROCHLORIDEDirectRXANDACurrent
61919-349ALFUZOSIN HYDROCHLORIDEALFUZOSIN HYDROCHLORIDEDirectRXANDACurrent
63629-2353Alfuzosin HydrochlorideAlfuzosin HydrochlorideBryant Ranch PrepackANDACurrent
63629-2353Alfuzosin HydrochlorideAlfuzosin HydrochlorideBryant Ranch PrepackANDACurrent
63629-2354Alfuzosin HydrochlorideAlfuzosin HydrochlorideBryant Ranch PrepackANDACurrent
63629-2354Alfuzosin HydrochlorideAlfuzosin HydrochlorideBryant Ranch PrepackANDACurrent
63629-9295Alfuzosin HydrochlorideAlfuzosin HydrochlorideBryant Ranch PrepackANDACurrent
70934-306Alfuzosin HydrochlorideAlfuzosin HydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-306Alfuzosin HydrochlorideAlfuzosin HydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-306Alfuzosin HydrochlorideAlfuzosin HydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71335-1529Alfuzosin HydrochlorideAlfuzosin HydrochlorideBryant Ranch PrepackANDACurrent
71335-1529Alfuzosin HydrochlorideAlfuzosin HydrochlorideBryant Ranch PrepackANDACurrent
71335-2146Alfuzosin HydrochlorideAlfuzosin HydrochlorideBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9214ORIG2011-07-20