FDA.reportPublic FDA data

Application 075034

Type
ANDA
Sponsor
APOTEX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GEMFIBROZILGEMFIBROZILTABLET;ORAL600MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
33261-146GemfibrozilGemfibrozilAidarex Pharmaceuticals LLCANDACurrent
50436-6540GemfibrozilGemfibrozilUnit Dose ServicesANDACurrent
53808-0368GemfibrozilGemfibrozilState of Florida DOH Central PharmacyANDACurrent
53808-0838GemfibrozilGemfibrozilState of Florida DOH Central PharmacyANDACurrent
60505-0034GemfibrozilGemfibrozilApotex Corp.ANDACurrent
63629-1390GemfibrozilGemfibrozilBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
42924ORIG1998-07-20
30736ORIG1998-07-20