FDA.reportPublic FDA data

Application 207405

Type
ANDA
Sponsor
ALKEM LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TAMSULOSIN HYDROCHLORIDETAMSULOSIN HYDROCHLORIDECAPSULE;ORAL0.4MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-3646Tamsulosin HydrochlorideTamsulosin HydrochlorideA-S Medication SolutionsANDACurrent
50090-3646Tamsulosin HydrochlorideTamsulosin HydrochlorideA-S Medication SolutionsANDACurrent
50090-3646Tamsulosin HydrochlorideTamsulosin HydrochlorideA-S Medication SolutionsANDACurrent
50090-4906Tamsulosin HydrochlorideTamsulosin HydrochlorideA-S Medication SolutionsANDACurrent
50268-740Tamsulosin HydrochlorideTamsulosin HydrochlorideAvPAKANDACurrent
50268-740Tamsulosin HydrochlorideTamsulosin HydrochlorideAvPAKANDACurrent
50268-740Tamsulosin HydrochlorideTamsulosin HydrochlorideAvPAKANDACurrent
55700-670Tamsulosin HydrochlorideTamsulosin HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-670Tamsulosin HydrochlorideTamsulosin HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
67296-1646Tamsulosin HydrochlorideTamsulosin HydrochlorideRedPharm Drug. Inc.ANDACurrent
67296-1646Tamsulosin HydrochlorideTamsulosin HydrochlorideRedPharm Drug. Inc.ANDACurrent
67877-450Tamsulosin HydrochlorideTamsulosin HydrochlorideAscend Laboratories, LLCANDACurrent
67877-450Tamsulosin HydrochlorideTamsulosin HydrochlorideAscend Laboratories, LLCANDACurrent
67877-450Tamsulosin HydrochlorideTamsulosin HydrochlorideAscend Laboratories, LLCANDACurrent
70518-1208Tamsulosin HydrochlorideTamsulosin HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1252Tamsulosin HydrochlorideTamsulosin HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1252Tamsulosin HydrochlorideTamsulosin HydrochlorideREMEDYREPACK INC.ANDACurrent
70934-771Tamsulosin HydrochlorideTamsulosin HydrochlorideDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
71205-217Tamsulosin HydrochlorideTamsulosin HydrochlorideProficient Rx LPANDACurrent
71205-217Tamsulosin HydrochlorideTamsulosin HydrochlorideProficient Rx LPANDACurrent
71205-217Tamsulosin HydrochlorideTamsulosin HydrochlorideProficient Rx LPANDACurrent
71335-1538Tamsulosin HydrochlorideTamsulosin HydrochlorideBryant Ranch PrepackANDACurrent