FDA.reportPublic FDA data

Application 091416

Type
ANDA
Sponsor
MARKSANS PHARMA

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
10544-111NAPROXENNAPROXENBlenheim Pharmacal, Inc.ANDACurrent
25000-138NaproxenNaproxenMARKSANS PHARMA LIMITEDANDACurrent
25000-138NaproxenNaproxenMARKSANS PHARMA LIMITEDANDACurrent
25000-138NaproxenNaproxenMARKSANS PHARMA LIMITEDANDACurrent
25000-138NaproxenNaproxenMARKSANS PHARMA LIMITEDANDACurrent
25000-139NaproxenNaproxenMARKSANS PHARMA LIMITEDANDACurrent
25000-139NaproxenNaproxenMARKSANS PHARMA LIMITEDANDACurrent
25000-139NaproxenNaproxenMARKSANS PHARMA LIMITEDANDACurrent
25000-139NaproxenNaproxenMARKSANS PHARMA LIMITEDANDACurrent
25000-140NaproxenNaproxenMARKSANS PHARMA LIMITEDANDACurrent
25000-140NaproxenNaproxenMARKSANS PHARMA LIMITEDANDACurrent
25000-140NaproxenNaproxenMARKSANS PHARMA LIMITEDANDACurrent
25000-140NaproxenNaproxenMARKSANS PHARMA LIMITEDANDACurrent
42708-140NAPROXENNAPROXENQPharma IncANDACurrent
43063-920NAPROXENNAPROXENPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-920NAPROXENNAPROXENPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-920NAPROXENNAPROXENPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-920NAPROXENNAPROXENPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-920NAPROXENNAPROXENPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-920NAPROXENNAPROXENPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-920NAPROXENNAPROXENPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-920NAPROXENNAPROXENPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-920NAPROXENNAPROXENPD-Rx Pharmaceuticals, InANDACurrent
43063-920NAPROXENNAPROXENPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-937NAPROXENNAPROXENPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-937NAPROXENNAPROXENPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-937NAPROXENNAPROXENPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-937NAPROXENNAPROXENPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-937NAPROXENNAPROXENPD-Rx Pharmaceuticals, Inc.ANDACurrent
45865-581NAPROXENNAPROXENmedsource pharmaceuticalsANDACurrent
49483-617NAPROXENNAPROXENTIME CAP LABORATORIESANDACurrent
49483-618NAPROXENNAPROXENTIME CAP LABORATORIESANDACurrent
49483-619NAPROXENNAPROXENTIME CAP LABORATORIESANDACurrent
50436-0618NAPROXENNAPROXENUnit Dose ServicesANDACurrent
52605-138NAPROXENNAPROXENPolygen Pharmaceuticals LLCANDACurrent
52605-139NAPROXENNAPROXENPolygen Pharmaceuticals LLCANDACurrent
52605-140NAPROXENNAPROXENPolygen Pharmaceuticals LLCANDACurrent
52959-193NAPROXENNAPROXENH.J. Harkins Company., Inc.ANDACurrent
53002-3110NAPROXENNAPROXENRPK Pharmaceuticals, Inc.ANDACurrent
53002-3110NAPROXENNAPROXENRPK Pharmaceuticals, Inc.ANDACurrent
60760-561NAPROXENNAPROXENSt. Mary's Medical Park PharmacyANDACurrent
66336-815NAPROXENNAPROXENDispensing Solutions, Inc.ANDACurrent
67296-1609NAPROXENNAPROXENRedPharm Drug, Inc.ANDACurrent
67296-1609NAPROXENNAPROXENRedPharm Drug, Inc.ANDACurrent
67296-1609NAPROXENNAPROXENRedPharm Drug, Inc.ANDACurrent
68071-3345NAPROXENNAPROXENNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3345NAPROXENNAPROXENNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4006NAPROXENNAPROXENNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4006NAPROXENNAPROXENNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4381NAPROXENNAPROXENNuCare Pharmaceuticals,InANDACurrent
68071-4381NAPROXENNAPROXENNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4381NAPROXENNAPROXENNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4510NAPROXENNAPROXENNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4510NAPROXENNAPROXENNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4510NAPROXENNAPROXENNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4995NAPROXENNAPROXENNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4995NAPROXENNAPROXENNuCare Pharmaceuticals,Inc.ANDACurrent
68788-6998NAPROXENNAPROXENPreferred Pharmaceuticals Inc.ANDACurrent
68788-7711NAPROXENNAPROXENPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7711NAPROXENNAPROXENPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7711NAPROXENNAPROXENPreferred Pharmaceuticals, Inc.ANDACurrent
69150-138NAPROXENNAPROXENBiomes PharmaceuticalsANDACurrent
69150-139NAPROXENNAPROXENBiomes PharmaceuticalsANDACurrent
69150-140NAPROXENNAPROXENBiomes PharmaceuticalsANDACurrent
70518-2428NAPROXENNAPROXENREMEDYREPACK INC.ANDACurrent
70518-2428NAPROXENNAPROXENREMEDYREPACK INC.ANDACurrent
70518-2428NAPROXENNAPROXENREMEDYREPACK INC.ANDACurrent
70934-124NAPROXENNAPROXENDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-124NAPROXENNAPROXENDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-124NAPROXENNAPROXENDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-455NAPROXENNAPROXENDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-455NAPROXENNAPROXENDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71335-0255NAPROXENNAPROXENBryant Ranch PrepackANDACurrent
71335-0255NAPROXENNAPROXENBryant Ranch PrepackANDACurrent
71335-0255NAPROXENNAPROXENBryant Ranch PrepackANDACurrent
71335-0973NAPROXENNAPROXENBryant Ranch PrepackANDACurrent
71335-0973NAPROXENNAPROXENBryant Ranch PrepackANDACurrent
71335-0973NAPROXENNAPROXENBryant Ranch PrepackANDACurrent
71335-0973NAPROXENNAPROXENBryant Ranch PrepackANDACurrent
71610-436NAPROXENNAPROXENAphena Pharma Solutions - Tennessee, LLCANDACurrent