FDA.reportPublic FDA data

Application 076159

Type
ANDA
Sponsor
PAR PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GLIPIZIDEGLIPIZIDETABLET, EXTENDED RELEASE;ORAL10MGNoNo
002GLIPIZIDEGLIPIZIDETABLET, EXTENDED RELEASE;ORAL5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10370-745GlipizideGlipizidePar Pharmaceutical, Inc.ANDACurrent
10370-745GlipizideGlipizidePar Pharmaceutical, Inc.ANDACurrent
10370-745GlipizideGlipizidePar Pharmaceutical, Inc.ANDACurrent
10370-745GlipizideGlipizidePar Pharmaceutical, Inc.ANDACurrent
10370-746GlipizideGlipizidePar Pharmaceutical, Inc.ANDACurrent
10370-746GlipizideGlipizidePar Pharmaceutical, Inc.ANDACurrent
10370-746GlipizideGlipizidePar Pharmaceutical, Inc.ANDACurrent
10370-746GlipizideGlipizidePar Pharmaceutical, Inc.ANDACurrent
50090-2915GlipizideGlipizideA-S Medication SolutionsANDACurrent
50090-2915GlipizideGlipizideA-S Medication SolutionsANDACurrent
50090-3069GlipizideGlipizideA-S Medication SolutionsANDACurrent
50090-3069GlipizideGlipizideA-S Medication SolutionsANDACurrent
50090-3069GlipizideGlipizideA-S Medication SolutionsANDACurrent
60760-745GlipizideGlipizideSt. Mary's Medical Park PharmacyANDACurrent
60760-746GlipizideGlipizideSt. Mary's Medical Park PharmacyANDACurrent
63629-2202GlipizideGlipizideBryant Ranch PrepackANDACurrent
63629-2202GlipizideGlipizideBryant Ranch PrepackANDACurrent
63629-2203GlipizideGlipizideBryant Ranch PrepackANDACurrent
63629-2203GlipizideGlipizideBryant Ranch PrepackANDACurrent
63629-2204GlipizideGlipizideBryant Ranch PrepackANDACurrent
63629-2204GlipizideGlipizideBryant Ranch PrepackANDACurrent
63629-2205GlipizideGlipizideBryant Ranch PrepackANDACurrent
63629-2205GlipizideGlipizideBryant Ranch PrepackANDACurrent
63629-9281GlipizideGlipizideBryant Ranch PrepackANDACurrent
68071-3141GlipizideGlipizideNuCare Pharmaceuticals Inc,ANDACurrent
68071-4020GlipizideGlipizideNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7230GlipizideGlipizidePreferred Pharmaceuticals Inc.ANDACurrent
68788-7230GlipizideGlipizidePreferred Pharmaceuticals Inc.ANDACurrent
68788-7230GlipizideGlipizidePreferred Pharmaceuticals Inc.ANDACurrent
70518-0389GlipizideGlipizideREMEDYREPACK INC.ANDACurrent
71335-0388GlipizideGlipizideBryant Ranch PrepackANDACurrent
71335-0388GlipizideGlipizideBryant Ranch PrepackANDACurrent
71335-0851GlipizideGlipizideBryant Ranch PrepackANDACurrent
71335-0851GlipizideGlipizideBryant Ranch PrepackANDACurrent