FDA.reportPublic FDA data

Application 074201

Type
ANDA
Sponsor
TEVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NAPROXENNAPROXENTABLET;ORAL250MGNoNo
002NAPROXENNAPROXENTABLET;ORAL375MGNoNo
003NAPROXENNAPROXENTABLET;ORAL500MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-1504NaproxenNaproxenNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-3562NaproxenNaproxenNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-3563NaproxenNaproxenNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7709NaproxenNaproxenNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
10544-010NaproxenNaproxenBlenheim Pharmacal, Inc.ANDACurrent
35356-684NaproxenNaproxenLake Erie Medical DBA Quality Care Products LLCANDACurrent
53808-0739NaproxenNAPROXENState of Florida DOH Central PharmacyANDACurrent
53808-0742Naproxen SodiumNAPROXEN SODIUMState of Florida DOH Central PharmacyANDACurrent
67296-0708NaproxenNaproxenRedPharm Drug, Inc.ANDACurrent
67296-0708NaproxenNaproxenRedPharm Drug, Inc.ANDACurrent