FDA.reportPublic FDA data

Application 075227

Type
ANDA
Sponsor
TEVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NAPROXENNAPROXENTABLET, DELAYED RELEASE;ORAL375MGNoNo
002NAPROXENNAPROXENTABLET, DELAYED RELEASE;ORAL500MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-1005NaproxenNaproxenTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1005NaproxenNaproxenTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1005NaproxenNaproxenTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1005NaproxenNaproxenTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1006NaproxenNaproxenTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1006NaproxenNaproxenTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1006NaproxenNaproxenTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1006NaproxenNaproxenTeva Pharmaceuticals USA, Inc.ANDACurrent
21695-343NaproxenNaproxenRebel Distributors CorpANDACurrent
33261-082NaproxenNaproxenAidarex Pharmaceuticals LLCANDACurrent
33261-083NaproxenNaproxenAidarex Pharmaceuticals LLCANDACurrent
45865-867NaproxenNaproxenmedsource pharmaceuticalsANDACurrent
45865-914NaproxenNaproxenmedsource pharmaceuticalsANDACurrent
45865-914NaproxenNaproxenmedsource pharmaceuticalsANDACurrent
49999-897NaproxenNaproxenLake Erie Medical DBA Quality Care Products LLCANDACurrent
50090-0608NaproxenNaproxenA-S Medication SolutionsANDACurrent
52959-516NaproxenNaproxenH.J. Harkins Company, Inc.ANDACurrent
55289-307NaproxenNaproxenPD-Rx Pharmaceuticals, Inc.ANDACurrent
63629-3795NaproxenNaproxenBryant Ranch PrepackANDACurrent
68151-2609NaproxenNaproxenCarilion Materials ManagementANDACurrent
68788-6908NaproxenNaproxenPreferred Pharmaceuticals Inc.ANDACurrent
68788-6908NaproxenNaproxenPreferred Pharmaceuticals Inc.ANDACurrent
68788-6908NaproxenNaproxenPreferred Pharmaceuticals Inc.ANDACurrent
68788-7072NaproxenNaproxenPreferred Pharmaceuticals Inc.ANDACurrent
68788-7072NaproxenNaproxenPreferred Pharmaceuticals Inc.ANDACurrent
68788-7072NaproxenNaproxenPreferred Pharmaceuticals Inc.ANDACurrent
70518-1064NaproxenNaproxenREMEDYREPACK INC.ANDACurrent
70518-1064NaproxenNaproxenREMEDYREPACK INC.ANDACurrent
71205-469NaproxenNaproxenProficient Rx LPANDACurrent
71205-469NaproxenNaproxenProficient Rx LPANDACurrent
71205-469NaproxenNaproxenProficient Rx LPANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
30804ORIG1998-06-30