FDA.reportPublic FDA data

Application 078329

Type
ANDA
Sponsor
STRIDES 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
0615-8309IbuprofenIbuprofenNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8309IbuprofenIbuprofenNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8309IbuprofenIbuprofenNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8310IBUPROFENIBUPROFENNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8310IbuprofenIbuprofenNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8311IbuprofenIbuprofenNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8311IbuprofenIbuprofenNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
10544-084ibuprofenibuprofenBlenheim Pharmacal, Inc.ANDACurrent
42291-428IbuprofenIbuprofenAvKARE, IncANDACurrent
42291-428IbuprofenIbuprofenAvKAREANDACurrent
42291-440IbuprofenIbuprofenAvKAREANDACurrent
42291-440IbuprofenIbuprofenAvKAREANDACurrent
42291-440IbuprofenIbuprofenAvKAREANDACurrent
42291-441IbuprofenIbuprofenAvKAREANDACurrent
42291-441IbuprofenIbuprofenAvKAREANDACurrent
42291-441IbuprofenIbuprofenAvKAREANDACurrent
42291-442IbuprofenIbuprofenAvKAREANDACurrent
42291-442IbuprofenIbuprofenAvKAREANDACurrent
42291-442IbuprofenIbuprofenAvKAREANDACurrent
42291-442IbuprofenIbuprofenAvKAREANDACurrent
42543-964IbuprofenIbuprofenStrides Pharma Inc.ANDACurrent
42543-964IbuprofenIbuprofenStrides Pharma Inc.ANDACurrent
42543-964IbuprofenIbuprofenStrides Pharma Inc.ANDACurrent
42543-964IbuprofenIbuprofenStrides Pharma Inc.ANDACurrent
42543-964IbuprofenIbuprofenStrides Pharma Inc.ANDACurrent
42543-965IbuprofenIbuprofenStrides Pharma Inc.ANDACurrent
42543-965IbuprofenIbuprofenStrides Pharma Inc.ANDACurrent
42543-965IbuprofenIbuprofenStrides Pharma Inc.ANDACurrent
42543-965IbuprofenIbuprofenStrides Pharma Inc.ANDACurrent
42543-965IbuprofenIbuprofenStrides Pharma Inc.ANDACurrent
42543-966IbuprofenIbuprofenStrides Pharma Inc.ANDACurrent
42543-966IbuprofenIbuprofenStrides Pharma Inc.ANDACurrent
42543-966IbuprofenIbuprofenStrides Pharma Inc.ANDACurrent
42543-966IbuprofenIbuprofenStrides Pharma Inc.ANDACurrent
42543-966IbuprofenIbuprofenStrides Pharma Inc.ANDACurrent
50090-5818IbuprofenIbuprofenA-S Medication SolutionsANDACurrent
50090-5819IbuprofenIbuprofenA-S Medication SolutionsANDACurrent
57910-100IbuprofenIbuprofenShasun Pharmaceuticals LimitedANDACurrent
57910-200IbuprofenIbuprofenShasun Pharmaceuticals LimitedANDACurrent
57910-300IbuprofenIbuprofenShasun Pharmaceuticals LimitedANDACurrent
60760-596IbuprofenIbuprofenSt. Mary's Medical Park PharmacyANDACurrent
60760-596IbuprofenIbuprofenSt. Mary's Medical Park PharmacyANDACurrent
60760-596IbuprofenIbuprofenSt. Mary's Medical Park PharmacyANDACurrent
60760-597IbuprofenIbuprofenSt. Mary's Medical Park PharmacyANDACurrent
60760-597IbuprofenIbuprofenSt. Mary's Medical Park PharmacyANDACurrent
60760-597IbuprofenIbuprofenSt. Mary's Medical Park PharmacyANDACurrent
60760-597IbuprofenIbuprofenSt. Mary's Medical Park PharmacyANDACurrent
64380-807IbuprofenIbuprofenStrides Pharma Science LimitedANDACurrent
64380-807IbuprofenIbuprofenStrides Pharma Science LimitedANDACurrent
64380-807IbuprofenIbuprofenStrides Pharma Science LimitedANDACurrent
64380-807IbuprofenIbuprofenStrides Pharma Science LimitedANDACurrent
64380-807IbuprofenIbuprofenStrides Pharma Science LimitedANDACurrent
64380-807IbuprofenIbuprofenStrides Shasun LimitedANDACurrent
64380-807IbuprofenIbuprofenStrides Pharma Science LimitedANDACurrent
64380-807IbuprofenIbuprofenStrides Pharma Science LimitedANDACurrent
64380-807IbuprofenIbuprofenStrides Pharma Science LimitedANDACurrent
64380-808IbuprofenIbuprofenStrides Pharma Science LimitedANDACurrent
64380-808IbuprofenIbuprofenStrides Pharma Science LimitedANDACurrent
64380-808IbuprofenIbuprofenStrides Pharma Science LimitedANDACurrent
64380-808IbuprofenIbuprofenStrides Shasun LimitedANDACurrent
64380-808IbuprofenIbuprofenStrides Pharma Science LimitedANDACurrent
64380-808IbuprofenIbuprofenStrides Pharma Science LimitedANDACurrent
64380-808IbuprofenIbuprofenStrides Pharma Science LimitedANDACurrent
64380-808IbuprofenIbuprofenStrides Pharma Science LimitedANDACurrent
64380-808IbuprofenIbuprofenStrides Pharma Science LimitedANDACurrent
64380-809IbuprofenIbuprofenStrides Pharma Science LimitedANDACurrent
64380-809IbuprofenIbuprofenStrides Pharma Science LimitedANDACurrent
64380-809IbuprofenIbuprofenStrides Pharma Science LimitedANDACurrent
64380-809IbuprofenIbuprofenStrides Shasun LimitedANDACurrent
64380-809IbuprofenIbuprofenStrides Pharma Science LimitedANDACurrent
64380-809IbuprofenIbuprofenStrides Pharma Science LimitedANDACurrent
64380-809IbuprofenIbuprofenStrides Pharma Science LimitedANDACurrent
64380-809IbuprofenIbuprofenStrides Pharma Science LimitedANDACurrent
64380-809IbuprofenIbuprofenStrides Pharma Science LimitedANDACurrent
67296-1686IbuprofenIbuprofenRedPharm Drug, Inc.ANDACurrent
67296-1686IbuprofenIbuprofenRedPharm Drug, Inc.ANDACurrent
67296-1706IbuprofenIbuprofenRedPharm Drug, Inc.ANDACurrent
67296-1706IbuprofenIbuprofenRedPharm Drug, Inc.ANDACurrent
67296-1716IbuprofenIbuprofenRedPharm Drug, Inc.ANDACurrent
67296-1716IbuprofenIbuprofenRedPharm Drug, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
23903ORIG2009-03-03