FDA.reportPublic FDA data

Application 090796

Type
ANDA
Sponsor
MARKSANS PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IBUPROFENIBUPROFENTABLET;ORAL400MGNoNo
002IBUPROFENIBUPROFENTABLET;ORAL600MGNoNo
003IBUPROFENIBUPROFENTABLET;ORAL800MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10544-201ibuprofenibuprofenBlenheim Pharmacal, Inc.ANDACurrent
10544-430ibuprofenibuprofenBlenheim Pharmacal, Inc.ANDACurrent
10544-431ibuprofenibuprofenBlenheim Pharmacal, Inc.ANDACurrent
10544-924ibuprofenibuprofenBlenheim Pharmacal, Inc.ANDACurrent
25000-121IbuprofenIbuprofenMARKSANS PHARMA LIMITEDANDACurrent
25000-121IbuprofenIbuprofenMARKSANS PHARMA LIMITEDANDACurrent
25000-121IbuprofenIbuprofenMARKSANS PHARMA LIMITEDANDACurrent
25000-121IbuprofenIbuprofenMARKSANS PHARMA LIMITEDANDACurrent
25000-121IbuprofenIbuprofenMARKSANS PHARMA LIMITEDANDACurrent
25000-121IbuprofenIbuprofenMARKSANS PHARMA LIMITEDANDACurrent
25000-122IbuprofenIbuprofenMARKSANS PHARMA LIMITEDANDACurrent
25000-122IbuprofenIbuprofenMARKSANS PHARMA LIMITEDANDACurrent
25000-122IbuprofenIbuprofenMARKSANS PHARMA LIMITEDANDACurrent
25000-122IbuprofenIbuprofenMARKSANS PHARMA LIMITEDANDACurrent
25000-122IbuprofenIbuprofenMARKSANS PHARMA LIMITEDANDACurrent
25000-122IbuprofenIbuprofenMARKSANS PHARMA LIMITEDANDACurrent
25000-123IbuprofenIbuprofenMARKSANS PHARMA LIMITEDANDACurrent
25000-123IbuprofenIbuprofenMARKSANS PHARMA LIMITEDANDACurrent
25000-123IbuprofenIbuprofenMARKSANS PHARMA LIMITEDANDACurrent
25000-123IbuprofenIbuprofenMARKSANS PHARMA LIMITEDANDACurrent
25000-123IbuprofenIbuprofenMARKSANS PHARMA LIMITEDANDACurrent
25000-123IbuprofenIbuprofenMARKSANS PHARMA LIMITEDANDACurrent
33358-187ibuprofenibuprofenRxChange Co.ANDACurrent
42582-111IbuprofenIbuprofenBi-Coastal Pharma International LLCANDACurrent
42582-112IbuprofenIbuprofenBi-Coastal Pharma International LLCANDACurrent
42582-113IbuprofenIbuprofenBi-Coastal Pharma International LLCANDACurrent
42708-097IbuprofenIbuprofenQPharma IncANDACurrent
42708-097IbuprofenIbuprofenQPharma IncANDACurrent
42708-097IbuprofenIbuprofenQPharma IncANDACurrent
42708-097IbuprofenIbuprofenQPharma IncANDACurrent
42708-097IbuprofenIbuprofenQPharma IncANDACurrent
42708-097IbuprofenIbuprofenQPharma IncANDACurrent
43063-858IBUPROFENIBUPROFENPD-Rx Pharmaceuticals, InANDACurrent
43063-858IBUPROFENIBUPROFENPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-858IBUPROFENIBUPROFENPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-858IBUPROFENIBUPROFENPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-858IBUPROFENIBUPROFENPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-858IBUPROFENIBUPROFENPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-858IBUPROFENIBUPROFENPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-858IBUPROFENIBUPROFENPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-858IBUPROFENIBUPROFENPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-858IBUPROFENIBUPROFENPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-867IBUPROFENIBUPROFENPD-Rx Pharmaceuticals, InANDACurrent
43063-867IBUPROFENIBUPROFENPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-867IBUPROFENIBUPROFENPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-867IBUPROFENIBUPROFENPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-867IBUPROFENIBUPROFENPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-867IBUPROFENIBUPROFENPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-867IBUPROFENIBUPROFENPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-872IBUPROFENIBUPROFENPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-872IBUPROFENIBUPROFENPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-872IBUPROFENIBUPROFENPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-872IBUPROFENIBUPROFENPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-872IBUPROFENIBUPROFENPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-872IBUPROFENIBUPROFENPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-872IBUPROFENIBUPROFENPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-872IBUPROFENIBUPROFENPD-Rx Pharmaceuticals, InANDACurrent
43063-872IBUPROFENIBUPROFENPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-914IBUPROFENIBUPROFENPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-914IBUPROFENIBUPROFENPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-914IBUPROFENIBUPROFENPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-914IBUPROFENIBUPROFENPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-914IBUPROFENIBUPROFENPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-936IBUPROFENIBUPROFENPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-936IBUPROFENIBUPROFENPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-936IBUPROFENIBUPROFENPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-936IBUPROFENIBUPROFENPD-Rx Pharmaceuticals, Inc.ANDACurrent
45865-117IBUPROFENIBUPROFENMedsource PharmaceuticalsANDACurrent
45865-945IBUPROFENIBUPROFENmedsource pharmaceuticalsANDACurrent
49483-602IBUPROFENIBUPROFENTIME CAP LABORATORIES, INCANDACurrent
49483-602IBUPROFENIBUPROFENTIME CAP LABORATORIES, INCANDACurrent
49483-603IBUPROFENIBUPROFENTIME CAP LABORATORIES, INCANDACurrent
49483-603IBUPROFENIBUPROFENTIME CAP LABORATORIES, INCANDACurrent
49483-604IBUPROFENIBUPROFENTIME CAP LABORATORIES, INCANDACurrent
49483-604IBUPROFENIBUPROFENTIME CAP LABORATORIES, INCANDACurrent
50090-5159IBUPROFENIBUPROFENA-S Medication SolutionsANDACurrent
50090-5159IBUPROFENIBUPROFENA-S Medication SolutionsANDACurrent
50090-5160IBUPROFENIBUPROFENA-S Medication SolutionsANDACurrent
50090-5160IBUPROFENIBUPROFENA-S Medication SolutionsANDACurrent
50090-5160IBUPROFENIBUPROFENA-S Medication SolutionsANDACurrent