FDA.report

Application 208834

Type
ANDA
Sponsor
AMNEAL PHARMS CO

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001ETODOLACETODOLACTABLET;ORAL400MGNoNo
002ETODOLACETODOLACTABLET;ORAL500MGNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-3963EtodolacEtodolacA-S Medication SolutionsANDACurrent
50090-3963EtodolacEtodolacA-S Medication SolutionsANDACurrent
50090-3963EtodolacEtodolacA-S Medication SolutionsANDACurrent
50090-3963EtodolacEtodolacA-S Medication SolutionsANDACurrent
50090-3974EtodolacEtodolacA-S Medication SolutionsANDACurrent
50090-3974EtodolacEtodolacA-S Medication SolutionsANDACurrent
50090-3974EtodolacEtodolacA-S Medication SolutionsANDACurrent
50090-3974EtodolacEtodolacA-S Medication SolutionsANDACurrent
50090-4053EtodolacEtodolacA-S Medication SolutionsANDACurrent
50090-4053EtodolacEtodolacA-S Medication SolutionsANDACurrent
51655-423EtodolacEtodolacNorthwind PharmaceuticalsANDACurrent
51655-423EtodolacEtodolacNorthwind PharmaceuticalsANDACurrent
68788-7300EtodolacEtodolacPreferred Pharmaceuticals Inc.ANDACurrent
68788-7300EtodolacEtodolacPreferred Pharmaceuticals Inc.ANDACurrent
68788-7300EtodolacEtodolacPreferred Pharmaceuticals Inc.ANDACurrent
68788-7300EtodolacEtodolacPreferred Pharmaceuticals Inc.ANDACurrent
68788-7300EtodolacEtodolacPreferred Pharmaceuticals Inc.ANDACurrent
68788-7315EtodolacEtodolacPreferred Pharmaceuticals Inc.ANDACurrent
68788-7315EtodolacEtodolacPreferred Pharmaceuticals Inc.ANDACurrent
68788-7315EtodolacEtodolacPreferred Pharmaceuticals Inc.ANDACurrent
68788-7315EtodolacEtodolacPreferred Pharmaceuticals Inc.ANDACurrent
69238-1342EtodolacEtodolacAmneal Pharmaceuticals NY LLCANDACurrent
69238-1342EtodolacEtodolacAmneal Pharmaceuticals NY LLCANDACurrent
69238-1342EtodolacEtodolacAmneal Pharmaceuticals NY LLCANDACurrent
69238-1342EtodolacEtodolacAmneal Pharmaceuticals NY LLCANDACurrent
69238-1342EtodolacEtodolacAmneal Pharmaceuticals NY LLCANDACurrent
69238-1342EtodolacEtodolacAmneal Pharmaceuticals LLCANDACurrent
69238-1343EtodolacEtodolacAmneal Pharmaceuticals NY LLCANDACurrent
69238-1343EtodolacEtodolacAmneal Pharmaceuticals NY LLCANDACurrent
69238-1343EtodolacEtodolacAmneal Pharmaceuticals NY LLCANDACurrent
69238-1343EtodolacEtodolacAmneal Pharmaceuticals LLCANDACurrent
69238-1343EtodolacEtodolacAmneal Pharmaceuticals NY LLCANDACurrent
69238-1343EtodolacEtodolacAmneal Pharmaceuticals NY LLCANDACurrent
69306-020EtodolacEtodolacDoc RxANDACurrent
69306-020EtodolacEtodolacDoc RxANDACurrent
69306-020EtodolacEtodolacDoc RxANDACurrent
69306-020EtodolacEtodolacDoc RxANDACurrent
70518-3163EtodolacEtodolacREMEDYREPACK INC.ANDACurrent
71335-0982EtodolacEtodolacBryant Ranch PrepackANDACurrent
71335-0982EtodolacEtodolacBryant Ranch PrepackANDACurrent
71335-0982EtodolacEtodolacBryant Ranch PrepackANDACurrent
71335-1230EtodolacEtodolacBryant Ranch PrepackANDACurrent
71335-1230EtodolacEtodolacBryant Ranch PrepackANDACurrent
80425-0140LodineEtodolac 400mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0140EtodolacEtodolacAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0140EtodolacEtodolacAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0140EtodolacEtodolacAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent