FDA.reportPublic FDA data

Application 090284

Type
ANDA
Sponsor
INVAGEN PHARMS

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
0440-5000Alfuzosin hydrochlorideAlfuzosin hydrochlorideLiberty Pharmaceuticals, Inc.ANDACurrent
31722-302Alfuzosin HydrochlorideAlfuzosin HydrochlorideCamber PharmaceuticalsANDACurrent
43353-945Alfuzosin hydrochlorideAlfuzosin hydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
69097-844Alfuzosin HydrochlorideAlfuzosin HydrochlorideCipla USA Inc.ANDACurrent
69097-844Alfuzosin HydrochlorideAlfuzosin HydrochlorideCipla USA Inc.ANDACurrent
70934-961Alfuzosin HydrochlorideAlfuzosin HydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-961Alfuzosin HydrochlorideAlfuzosin HydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
76282-302Alfuzosin hydrochlorideAlfuzosin hydrochlorideExelan Pharmaceuticals Inc.ANDACurrent
76282-302Alfuzosin hydrochlorideAlfuzosin hydrochlorideExelan Pharmaceuticals Inc.ANDACurrent
76282-302Alfuzosin hydrochlorideAlfuzosin hydrochlorideExelan Pharmaceuticals Inc.ANDACurrent