FDA.reportPublic FDA data

Application 091432

Type
ANDA
Sponsor
SUNRISE PHARM INC

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
10544-920NaproxenNaproxenBlenheim Pharmacal, Inc.ANDACurrent
31722-338NaproxenNaproxenCamber PharmaceuticalsANDACurrent
31722-339NaproxenNaproxenCamber PharmaceuticalsANDACurrent
42291-629NaproxenNaproxenAvKARE, Inc.ANDACurrent
42291-629NaproxenNaproxenAvKARE, Inc.ANDACurrent
42291-629NaproxenNaproxenAvKARE, Inc.ANDACurrent
42291-630NaproxenNaproxenAvKARE, Inc.ANDACurrent
42291-630NaproxenNaproxenAvKARE, Inc.ANDACurrent
42291-630NaproxenNaproxenAvKARE, Inc.ANDACurrent
45865-948NaproxenNaproxenmedsource pharmaceuticalsANDACurrent
50090-3025NaproxenNaproxenA-S Medication SolutionsANDACurrent
50090-3025NaproxenNaproxenA-S Medication SolutionsANDACurrent
50090-3524NaproxenNaproxenA-S Medication SolutionsANDACurrent
51655-628Naproxen Delayed ReleaseNaproxen Delayed ReleaseNorthwind PharmaceuticalsANDACurrent
53217-405NaproxenNaproxenAidarex Pharmaceuticals LLCANDACurrent
66267-373NaproxenNaproxenNuCare Pharmaceuticals,Inc.ANDACurrent
66267-373NaproxenNaproxenNuCare Pharmaceuticals,Inc.ANDACurrent
68788-6322NaproxenNaproxenPreferred Pharmaceuticals Inc.ANDACurrent
68788-6322NaproxenNaproxenPreferred Pharmaceuticals Inc.ANDACurrent
69097-851NaproxenNaproxenCipla USA Inc.ANDACurrent
69097-851NaproxenNaproxenCipla USA Inc.ANDACurrent
69097-852NaproxenNaproxenCipla USA Inc.ANDACurrent
69097-852NaproxenNaproxenCipla USA Inc.ANDACurrent
69543-425NAPROXENNAPROXENVirtus Pharmaceuticals, LLCANDACurrent
69543-425NAPROXENNAPROXENVirtus Pharmaceuticals, LLCANDACurrent
69543-426NAPROXENNAPROXENVirtus Pharmaceuticals, LLCANDACurrent
69543-426NAPROXENNAPROXENVirtus Pharmaceuticals, LLCANDACurrent
70518-1408NaproxenNaproxenREMEDYREPACK INC.ANDACurrent
70518-1408NaproxenNaproxenREMEDYREPACK INC.ANDACurrent
70518-1408NaproxenNaproxenREMEDYREPACK INC.ANDACurrent
71205-060NaproxenNaproxenProficient Rx LPANDACurrent
71205-060NaproxenNaproxenProficient Rx LPANDACurrent
71335-0318NaproxenNaproxenBryant Ranch PrepackANDACurrent
71335-0318NaproxenNaproxenBryant Ranch PrepackANDACurrent
72789-003NaproxenNaproxenPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-003NaproxenNaproxenPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-003NaproxenNaproxenPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-003NaproxenNaproxenPD-Rx Pharmaceuticals, Inc.ANDACurrent