FDA.reportPublic FDA data

Application 211626

Type
ANDA
Sponsor
GRAVITI PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FENOFIBRIC ACIDCHOLINE FENOFIBRATECAPSULE, DELAYED RELEASE;ORALEQ 45MG FENOFIBRIC ACIDNoNo
002FENOFIBRIC ACIDCHOLINE FENOFIBRATECAPSULE, DELAYED RELEASE;ORALEQ 135MG FENOFIBRIC ACIDNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42385-944FENOFIBRIC ACID DELAYED-RELEASEFENOFIBRIC ACIDLaurus Labs LimitedANDACurrent
42385-944FENOFIBRIC ACID DELAYED-RELEASEFENOFIBRIC ACIDLaurus Labs LimitedANDACurrent
42385-944FENOFIBRIC ACID DELAYED-RELEASEFENOFIBRIC ACIDLaurus Labs LimitedANDACurrent
42385-945FENOFIBRIC ACID DELAYED-RELEASEFenofibric AcidLaurus Labs LimitedANDACurrent
42385-945FENOFIBRIC ACID DELAYED-RELEASEFenofibric AcidLaurus Labs LimitedANDACurrent
42385-945FENOFIBRIC ACID DELAYED-RELEASEFenofibric AcidLaurus Labs LimitedANDACurrent
69315-281FENOFIBRIC ACIDFENOFIBRIC ACIDLeading Pharma, LLCANDACurrent
69315-282FENOFIBRIC ACIDFENOFIBRIC ACIDLeading Pharma, LLCANDACurrent
69844-022FENOFIBRIC ACID DELAYED-RELEASEFENOFIBRIC ACIDGraviti Pharmaceuticals Private LimitedANDACurrent
69844-022FENOFIBRIC ACID DELAYED-RELEASEFENOFIBRIC ACIDGraviti Pharmaceuticals Private LimitedANDACurrent
69844-022FENOFIBRIC ACID DELAYED-RELEASEFENOFIBRIC ACIDGraviti Pharmaceuticals Private LimitedANDACurrent
69844-022FENOFIBRIC ACID DELAYED-RELEASEFENOFIBRIC ACIDGraviti Pharmaceuticals Private LimitedANDACurrent
69844-023FENOFIBRIC ACID DELAYED-RELEASEFenofibric AcidGraviti Pharmaceuticals Private LimitedANDACurrent
69844-023FENOFIBRIC ACID DELAYED-RELEASEFenofibric AcidGraviti Pharmaceuticals Private LimitedANDACurrent
69844-023FENOFIBRIC ACID DELAYED-RELEASEFenofibric AcidGraviti Pharmaceuticals Private LimitedANDACurrent
69844-023FENOFIBRIC ACID DELAYED-RELEASEFenofibric AcidGraviti Pharmaceuticals Private LimitedANDACurrent