FDA.reportPublic FDA data

Application 201089

Type
ANDA
Sponsor
ACTAVIS LABS FL INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DICLOFENAC SODIUM AND MISOPROSTOLDICLOFENAC SODIUM; MISOPROSTOLTABLET, DELAYED RELEASE;ORAL50MG;0.2MGNoNo
002DICLOFENAC SODIUM AND MISOPROSTOLDICLOFENAC SODIUM; MISOPROSTOLTABLET, DELAYED RELEASE;ORAL75MG;0.2MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0591-0397Diclofenac Sodium and MisoprostolDiclofenac Sodium and MisoprostolActavis Pharma, Inc.ANDACurrent
0591-0397Diclofenac Sodium and MisoprostolDiclofenac Sodium and MisoprostolActavis Pharma, Inc.ANDACurrent
0591-0397Diclofenac Sodium and MisoprostolDiclofenac Sodium and MisoprostolActavis Pharma, Inc.ANDACurrent
0591-0397Diclofenac Sodium and MisoprostolDiclofenac Sodium and MisoprostolActavis Pharma, Inc.ANDACurrent
0591-0397Diclofenac Sodium and MisoprostolDiclofenac Sodium and MisoprostolActavis Pharma, Inc.ANDACurrent
0591-0397Diclofenac Sodium and MisoprostolDiclofenac Sodium and MisoprostolActavis Pharma, Inc.ANDACurrent
0591-0397Diclofenac Sodium and MisoprostolDiclofenac Sodium and MisoprostolActavis Pharma, Inc.ANDACurrent
0591-0397Diclofenac Sodium and MisoprostolDiclofenac Sodium and MisoprostolActavis Pharma, Inc.ANDACurrent
0591-0398Diclofenac Sodium and MisoprostolDiclofenac Sodium and MisoprostolActavis Pharma, Inc.ANDACurrent
0591-0398Diclofenac Sodium and MisoprostolDiclofenac Sodium and MisoprostolActavis Pharma, Inc.ANDACurrent
0591-0398Diclofenac Sodium and MisoprostolDiclofenac Sodium and MisoprostolActavis Pharma, Inc.ANDACurrent
0591-0398Diclofenac Sodium and MisoprostolDiclofenac Sodium and MisoprostolActavis Pharma, Inc.ANDACurrent
0591-0398Diclofenac Sodium and MisoprostolDiclofenac Sodium and MisoprostolActavis Pharma, Inc.ANDACurrent
0591-0398Diclofenac Sodium and MisoprostolDiclofenac Sodium and MisoprostolActavis Pharma, Inc.ANDACurrent
0591-0398Diclofenac Sodium and MisoprostolDiclofenac Sodium and MisoprostolActavis Pharma, Inc.ANDACurrent
0591-0398Diclofenac Sodium and MisoprostolDiclofenac Sodium and MisoprostolActavis Pharma, Inc.ANDACurrent
10544-949Diclofenac Sodium and MisoprostolDiclofenac Sodium and MisoprostolBlenheim Pharmacal, Inc.ANDACurrent
42291-232Diclofenac Sodium and MisoprostolDiclofenac Sodium and MisoprostolAvKARE, Inc.ANDACurrent
42291-232Diclofenac Sodium and MisoprostolDiclofenac Sodium and MisoprostolAvKAREANDACurrent
42291-232Diclofenac Sodium and MisoprostolDiclofenac Sodium and MisoprostolAvKAREANDACurrent
42291-233Diclofenac Sodium and MisoprostolDiclofenac Sodium and MisoprostolAvKAREANDACurrent
42291-233Diclofenac Sodium and MisoprostolDiclofenac Sodium and MisoprostolAvKAREANDACurrent
42291-233Diclofenac Sodium and MisoprostolDiclofenac Sodium and MisoprostolAvKARE, Inc.ANDACurrent
63629-4970Diclofenac Sodium and MisoprostolDiclofenac Sodium and MisoprostolBryant Ranch PrepackANDACurrent
63629-4970Diclofenac Sodium and MisoprostolDiclofenac Sodium and MisoprostolBryant Ranch PrepackANDACurrent
63629-4970Diclofenac Sodium and MisoprostolDiclofenac Sodium and MisoprostolBryant Ranch PrepackANDACurrent
63629-7034Diclofenac Sodium and MisoprostolDiclofenac Sodium and MisoprostolBryant Ranch PrepackANDACurrent
63629-7034Diclofenac Sodium and MisoprostolDiclofenac Sodium and MisoprostolBryant Ranch PrepackANDACurrent
68001-231Diclofenac Sodium and MisoprostolDiclofenac Sodium and MisoprostolBluePoint LaboratoriesANDACurrent
68001-231Diclofenac Sodium and MisoprostolDiclofenac Sodium and MisoprostolBluePoint LaboratoriesANDACurrent
68001-231Diclofenac Sodium and MisoprostolDiclofenac Sodium and MisoprostolBluePoint LaboratoriesANDACurrent
68001-231Diclofenac Sodium and MisoprostolDiclofenac Sodium and MisoprostolBluePoint LaboratoriesANDACurrent
68001-231Diclofenac Sodium and MisoprostolDiclofenac Sodium and MisoprostolBluePoint LaboratoriesANDACurrent
68001-232Diclofenac Sodium and MisoprostolDiclofenac Sodium and MisoprostolBluePoint LaboratoriesANDACurrent
68001-232Diclofenac Sodium and MisoprostolDiclofenac Sodium and MisoprostolBluePoint LaboratoriesANDACurrent
68001-232Diclofenac Sodium and MisoprostolDiclofenac Sodium and MisoprostolBluePoint LaboratoriesANDACurrent
68001-232Diclofenac Sodium and MisoprostolDiclofenac Sodium and MisoprostolBluePoint LaboratoriesANDACurrent
68001-232Diclofenac Sodium and MisoprostolDiclofenac Sodium and MisoprostolBluePoint LaboratoriesANDACurrent
68788-9290Diclofenac Sodium and MisoprostolDiclofenac Sodium and MisoprostolPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9290Diclofenac Sodium and MisoprostolDiclofenac Sodium and MisoprostolPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9290Diclofenac Sodium and MisoprostolDiclofenac Sodium and MisoprostolPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9290Diclofenac Sodium and MisoprostolDiclofenac Sodium and MisoprostolPreferred Pharmaceuticals, Inc.ANDACurrent
70518-3261Diclofenac Sodium and MisoprostolDiclofenac Sodium and MisoprostolREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22843ORIG2012-10-12
9858ORIG2012-07-11