FDA.reportPublic FDA data

Application 090545

Type
ANDA
Sponsor
MARKSANS PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NAPROXEN SODIUMNAPROXEN SODIUMTABLET;ORAL220MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-6099ALL DAY PAIN RELIEFNAPROXEN SODIUMWALGREENSANDACurrent
0363-9608ALL DAY PAIN RELIEFNAPROXEN SODIUMWALGREENSANDACurrent
0363-9608ALL DAY PAIN RELIEFNAPROXEN SODIUMWALGREENSANDACurrent
0363-9608ALL DAY PAIN RELIEFNAPROXEN SODIUMWALGREENSANDACurrent
0363-9608ALL DAY PAIN RELIEFNAPROXEN SODIUMWALGREENSANDACurrent
0363-9608ALL DAY PAIN RELIEFNAPROXEN SODIUMWALGREENSANDACurrent
0363-9609BACK AND MUSCLE PAINNAPROXENWALGREENSANDACurrent
0363-9609BACK AND MUSCLE PAINNAPROXENWALGREENSANDACurrent
0536-1022All Day ReliefNaproxen Sodium, Coated TabletsRugby LaboratoriesANDACurrent
0536-1023All Day ReliefNaproxen Sodium Tablet, coatedRugby LaboratoriesANDACurrent
25000-141Naproxen SodiumNaproxen Sodium, Coated TabletsMARKSANS PHARMA LIMITEDANDACurrent
25000-141Naproxen SodiumNaproxen Sodium, Coated TabletsMARKSANS PHARMA LIMITEDANDACurrent
25000-141Naproxen SodiumNaproxen Sodium, Coated TabletsMARKSANS PHARMA LIMITEDANDACurrent
25000-144Naproxen SodiumNaproxen Sodium Tablet, coatedMARKSANS PHARMA LIMITEDANDACurrent
25000-144Naproxen SodiumNaproxen Sodium Tablet, coatedMARKSANS PHARMA LIMITEDANDACurrent
25000-144Naproxen SodiumNaproxen Sodium Tablet, coatedMARKSANS PHARMA LIMITEDANDACurrent
27854-505Flanax Pain Reliever/Fever reducerNaproxen SodiumBelmora LLCANDACurrent
27854-555Belmora FlanaxNaproxen SodiumBelmora LLCANDACurrent
27854-555Belmora FlanaxNaproxen SodiumBelmora LLCANDACurrent
27854-555Belmora FlanaxNaproxen SodiumBelmora LLCANDACurrent
27854-555Belmora FlanaxNaproxen SodiumBelmora LLCANDACurrent
27854-555Belmora FlanaxNaproxen SodiumBelmora LLCANDACurrent
27854-555Belmora FlanaxNaproxen SodiumBelmora LLCANDACurrent
27854-555Belmora FlanaxNaproxen SodiumBelmora LLCANDACurrent
35418-000NaproxenNaproxen SodiumZee Medical IncANDACurrent
41226-609NAPROXEN SODIUMNAPROXEN SODIUMKroger CompanyANDACurrent
48201-007CALMADOL PAIN RELIEVERNaproxen SodiumGrandall Distributing Co., Inc.ANDACurrent
48201-007CALMADOL PAIN RELIEVERNaproxen SodiumGrandall Distributing Co., Inc.ANDACurrent
48201-007CALMADOL PAIN RELIEVERNaproxen SodiumGrandall Distributing Co., Inc.ANDACurrent
49483-608NAPROXEN SODIUMNAPROXEN SODIUMTIME CAP LABORATORIES, INCANDACurrent
49483-608NAPROXEN SODIUMNAPROXEN SODIUMTIME CAP LABORATORIES, INCANDACurrent
49483-609NAPROXEN SODIUMNAPROXEN SODIUMTIME CAP LABORATORIES, INCANDACurrent
49483-609NAPROXEN SODIUMNAPROXEN SODIUMTIME CAP LABORATORIES, INCANDACurrent
51824-030CAREALL NaproxenNaproxen SodiumNew World Imports, Inc.ANDACurrent
52605-141Naproxen SodiumNaproxen SodiumPolygen Pharmaceuticals LLCANDACurrent
52605-144Naproxen SodiumNaproxen SodiumPolygen Pharmaceuticals LLCANDACurrent
53185-362Naproxen Sodium 220mgNaproxen Sodium 220mgAthlete's Needs, Inc.ANDACurrent
53185-362Naproxen Sodium 220mgNaproxen Sodium 220mgAthlete's Needs, Inc.ANDACurrent
53185-362Naproxen Sodium 220mgNaproxen Sodium 220mgAthlete's Needs, Inc.ANDACurrent
53185-394Naproxen Sodium 220mgNaproxen Sodium 220mgAthlete's Needs, Inc.ANDACurrent
53185-394Naproxen Sodium 220mgNaproxen Sodium 220mgAthlete's Needs, Inc.ANDACurrent
53185-394Naproxen Sodium 220mgNaproxen Sodium 220mgAthlete's Needs, Inc.ANDACurrent
53329-688Naproxen Sodium 220mgNaproxen SodiumMedline IndustriesANDACurrent
53329-688Naproxen Sodium 220mgNaproxen SodiumMedline Industries, LPANDACurrent
53329-688Naproxen Sodium 220mgNaproxen SodiumMedline Industries, LPANDACurrent
53329-688Naproxen Sodium 220mgNaproxen SodiumMedline IndustriesANDACurrent
53329-688Naproxen Sodium 220mgNaproxen SodiumMedline IndustriesANDACurrent
57896-951Naproxen SodiumNaproxen SodiumGeri-Care Pharmaceutical CorpANDACurrent
59105-003NAPROXEN SODIUMNAPROXEN SODIUMJ.P. BUSINESS ENTERPRISEANDACurrent
61919-470NAPROXEN SODIUMNAPROXEN SODIUMDIRECT RXANDACurrent
61919-470NAPROXEN SODIUMNAPROXEN SODIUMDIRECT RXANDACurrent
61919-470NAPROXEN SODIUMNAPROXEN SODIUMDIRECT RXANDACurrent
63187-986Naproxen SodiumNaproxen SodiumProficient Rx LPANDACurrent
63187-986Naproxen SodiumNaproxen SodiumProficient Rx LPANDACurrent
63629-7773Naproxen SodiumNaproxen SodiumBryant Ranch PrepackANDACurrent
63629-7773Naproxen SodiumNaproxen SodiumBryant Ranch PrepackANDACurrent
67060-000NAPROXEN SODIUMNAPROXEN SODIUMADVANCED FIRST AID, INC.ANDACurrent
68071-3223Naproxen SodiumNaproxen SodiumNuCare Pharmaceuticals,Inc.ANDACurrent
68210-0030ALL DAY PAIN RELIEFNAPROXEN SODIUMSPIRIT PHARMACEUTICALS LLCANDACurrent
68210-0030ALL DAY PAIN RELIEFNAPROXEN SODIUMSPIRIT PHARMACEUTICALS LLCANDACurrent
68210-0400NAPROXEN SODIUMNAPROXEN SODIUMSPIRIT PHARMACEUTICALS,LLCANDACurrent
68210-0400NAPROXEN SODIUMNAPROXEN SODIUMSPIRIT PHARMACEUTICALS,LLCANDACurrent
68210-0400NAPROXEN SODIUMNAPROXEN SODIUMSPIRIT PHARMACEUTICALS,LLCANDACurrent
68210-0400NAPROXEN SODIUMNAPROXEN SODIUMSPIRIT PHARMACEUTICALS,LLCANDACurrent
68788-7367Naproxen SodiumNaproxen SodiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7367Naproxen SodiumNaproxen SodiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7367Naproxen SodiumNaproxen SodiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-9971All Day ReliefNaproxen Sodium Tablet, coatedPreferred Pharmaceuticals Inc.ANDACurrent
69168-361NaproxenNaproxen Sodium 220 mgAllegiant HealthANDACurrent
69168-361NaproxenNAPROXEN SODIUM 220 MGAllegiant HealthANDACurrent
69168-362Naproxen CapletsNaproxen Sodium 220 mgAllegiant HealthANDACurrent
69168-362Naproxen CapletsNaproxen Sodium 220 mgAllegiant HealthANDACurrent
69168-362Naproxen CapletsNaproxen Sodium 220 mgAllegiant HealthANDACurrent
69168-394Naproxen CapletsNaproxen Sodium 220 mgAllegiant HealthANDACurrent
69168-394Naproxen CapletsNaproxen Sodium 220 mgAllegiant HealthANDACurrent
69168-394Naproxen CapletsNaproxen Sodium 220 mgAllegiant HealthANDACurrent
69168-395Naproxen Sodium 220mgNaproxen Sodium 220mgAllegiant HealthANDACurrent
69168-395Naproxen Sodium 220mgNaproxen Sodium 220mgAllegiant HealthANDACurrent
69168-395Naproxen Sodium 220mgNaproxen Sodium 220mgAllegiant HealthANDACurrent
69168-632Naproxen SodiumNaproxen Sodium 220mgAllegiant HealthANDACurrent