FDA.reportPublic FDA data

Application 075289

Type
ANDA
Sponsor
VALEANT PHARMS NORTH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NIFEDIPINENIFEDIPINETABLET, EXTENDED RELEASE;ORAL60MGNoNo
002NIFEDIPINENIFEDIPINETABLET, EXTENDED RELEASE;ORAL30MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-2939NifedipinenifedipineA-S Medication SolutionsANDACurrent
53217-010NifedicalXLnifedipineAidarex Pharmaceuticals LLCANDACurrent
53808-0851NifedicalnifedipineState of Florida DOH Central PharmacyANDACurrent
55154-4837NifedicalnifedipineCardinal HealthANDACurrent
63629-1559NifedicalnifedipineBryant Ranch PrepackANDACurrent
68071-3025NifedipinenifedipineNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4281nifedipinenifedipineNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4281nifedipinenifedipineNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4281nifedipinenifedipineNuCare Pharmaceuticals,Inc.ANDACurrent
68682-108nifedipinenifedipineOceanside PharmaceuticalsANDACurrent
68682-108nifedipinenifedipineOceanside PharmaceuticalsANDACurrent
68682-108nifedipinenifedipineOceanside PharmaceuticalsANDACurrent
68682-109nifedipinenifedipineOceanside PharmaceuticalsANDACurrent
68682-109nifedipinenifedipineOceanside PharmaceuticalsANDACurrent
68682-109nifedipinenifedipineOceanside PharmaceuticalsANDACurrent
70518-1740nifedipinenifedipineREMEDYREPACK INC.ANDACurrent
70518-1740nifedipinenifedipineREMEDYREPACK INC.ANDACurrent
70934-963nifedipinenifedipineDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71335-0744nifedipinenifedipineBryant Ranch PrepackANDACurrent
71335-0744nifedipinenifedipineBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22455ORIG2005-07-22
8601SUPPL2001-02-06