FDA.reportPublic FDA data

Application 091305

Type
ANDA
Sponsor
INVAGEN PHARMS

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
10544-939NaproxenNaproxenBlenheim Pharmacal, Inc.ANDACurrent
31722-340NaproxenNaproxenCamber PharmaceuticalsANDACurrent
31722-341NaproxenNaproxenCamber PharmaceuticalsANDACurrent
31722-342NaproxenNaproxenCamber PharmaceuticalsANDACurrent
43353-201NaproxenNaproxenAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-211NaproxenNaproxenAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-216NaproxenNaproxenAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-218NaproxenNaproxenAphena Pharma Solutions - Tennessee, LLCANDACurrent
50090-4396naproxennaproxenA-S Medication SolutionsANDACurrent
53002-3100naproxennaproxenRPK Pharmaceuticals, Inc.ANDACurrent
53002-3100naproxennaproxenRPK Pharmaceuticals, Inc.ANDACurrent
53002-3100naproxennaproxenRPK Pharmaceuticals, Inc.ANDACurrent
53002-3112naproxennaproxenRPK Pharmaceuticals, Inc.ANDACurrent
53002-3112naproxennaproxenRPK Pharmaceuticals, Inc.ANDACurrent
53002-3112naproxennaproxenRPK Pharmaceuticals, Inc.ANDACurrent
53002-3240naproxennaproxenRPK Pharmaceuticals, Inc.ANDACurrent
53002-3240naproxennaproxenRPK Pharmaceuticals, Inc.ANDACurrent
53002-3240naproxennaproxenRPK Pharmaceuticals, Inc.ANDACurrent
53808-1053NaproxenNaproxenState of Florida DOH Central PharmacyANDACurrent
55700-463naproxennaproxenLake Erie Medical DBA Quality Care Products LLCANDACurrent
60687-268NaproxenNaproxenAmerican Health PackagingANDACurrent
60687-268NaproxenNaproxenAmerican Health PackagingANDACurrent
60760-460NaproxenNaproxenSt. Mary's Medical Park PharmacyANDACurrent
61919-586NAPROXENNAPROXENDirectRXANDACurrent
61919-586NAPROXENNAPROXENDirectRXANDACurrent
67296-1374naproxennaproxenRedPharm Drug, Inc.ANDACurrent
68071-3029naproxennaproxenNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3066naproxennaproxenNuCare Pharmaceuticals, Inc.ANDACurrent
68788-7456naproxennaproxenPreferred Pharmaceuticals Inc.ANDACurrent
68788-9878NaproxenNaproxenPreferred Pharmaceuticals Inc.ANDACurrent
69097-853naproxennaproxenCipla USA Inc.ANDACurrent
69097-853naproxennaproxenCipla USA Inc.ANDACurrent
69097-854naproxennaproxenCipla USA Inc.ANDACurrent
69097-854naproxennaproxenCipla USA Inc.ANDACurrent
69097-855naproxennaproxenCipla USA Inc.ANDACurrent
69097-855naproxennaproxenCipla USA Inc.ANDACurrent
70518-0596naproxennaproxenREMEDYREPACK INC.ANDACurrent
70518-0596naproxennaproxenREMEDYREPACK INC.ANDACurrent
70518-1511naproxennaproxenREMEDYREPACK INC.ANDACurrent
70518-1511naproxennaproxenREMEDYREPACK INC.ANDACurrent
71335-0386naproxennaproxenBryant Ranch PrepackANDACurrent
71335-0386naproxennaproxenBryant Ranch PrepackANDACurrent
76282-340NaproxenNaproxenExelan Pharmaceuticals, Inc.ANDACurrent
76282-340NaproxenNaproxenExelan Pharmaceuticals, Inc.ANDACurrent
76282-340NaproxenNaproxenExelan Pharmaceuticals, Inc.ANDACurrent
76282-341NaproxenNaproxenExelan Pharmaceuticals, Inc.ANDACurrent
76282-341NaproxenNaproxenExelan Pharmaceuticals, Inc.ANDACurrent
76282-341NaproxenNaproxenExelan Pharmaceuticals, Inc.ANDACurrent
76282-342NaproxenNaproxenExelan Pharmaceuticals, Inc.ANDACurrent
76282-342NaproxenNaproxenExelan Pharmaceuticals, Inc.ANDACurrent
76282-342NaproxenNaproxenExelan Pharmaceuticals, Inc.ANDACurrent