FDA.reportPublic FDA data

Application 075126

Type
ANDA
Sponsor
ANI PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ETODOLACETODOLACCAPSULE;ORAL200MGNoNo
002ETODOLACETODOLACCAPSULE;ORAL300MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
21695-049EtodolacEtodolacRebel Distributors CorpANDACurrent
50090-2132EtodolacEtodolacA-S Medication SolutionsANDACurrent
50090-2132EtodolacEtodolacA-S Medication SolutionsANDACurrent
52959-483ETODOLACETODOLACH. J. Harkins Co., IncANDACurrent
62559-250EtodolacEtodolacANI Pharmaceuticals, Inc.ANDACurrent
62559-250EtodolacEtodolacANI Pharmaceuticals, Inc.ANDACurrent
62559-250EtodolacEtodolacANI Pharmaceuticals, Inc.ANDACurrent
62559-251EtodolacEtodolacANI Pharmaceuticals, Inc.ANDACurrent
62559-251EtodolacEtodolacANI Pharmaceuticals, Inc.ANDACurrent
62559-251EtodolacEtodolacANI Pharmaceuticals, Inc.ANDACurrent
63629-1935EtodolacEtodolacBryant Ranch PrepackANDACurrent
63629-1935EtodolacEtodolacBryant Ranch PrepackANDACurrent
63629-1935EtodolacEtodolacBryant Ranch PrepackANDACurrent
63629-1936EtodolacEtodolacBryant Ranch PrepackANDACurrent
63629-1936EtodolacEtodolacBryant Ranch PrepackANDACurrent
63629-1936EtodolacEtodolacBryant Ranch PrepackANDACurrent
63629-3641EtodolacEtodolacBryant Ranch PrepackANDACurrent
63629-3641EtodolacEtodolacBryant Ranch PrepackANDACurrent
63629-3641EtodolacEtodolacBryant Ranch PrepackANDACurrent
67296-1271EtodolacEtodolacRedPharm Drug, Inc.ANDACurrent
67296-1271EtodolacEtodolacRedPharm Drug, Inc.ANDACurrent
67296-1271EtodolacEtodolacRedPharm Drug, Inc.ANDACurrent
70934-282EtodolacEtodolacDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-282EtodolacEtodolacDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8529ORIG1999-09-16