FDA.reportPublic FDA data

Application 203192

Type
ANDA
Sponsor
UNICHEM LABS LTD

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
29300-155Alfuzosin hydrochlorideAlfuzosin hydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-155Alfuzosin hydrochlorideAlfuzosin hydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-155Alfuzosin hydrochlorideAlfuzosin hydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-155Alfuzosin hydrochlorideAlfuzosin hydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-155Alfuzosin hydrochlorideAlfuzosin hydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
63629-7907Alfuzosin hydrochlorideAlfuzosin hydrochlorideBryant Ranch PrepackANDACurrent
63629-7907Alfuzosin hydrochlorideAlfuzosin hydrochlorideBryant Ranch PrepackANDACurrent
63629-7907Alfuzosin hydrochlorideAlfuzosin hydrochlorideBryant Ranch PrepackANDACurrent
63629-9155Alfuzosin hydrochlorideAlfuzosin hydrochlorideBryant Ranch PrepackANDACurrent
63629-9155Alfuzosin hydrochlorideAlfuzosin hydrochlorideBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
32391ORIG2016-01-29