FDA.reportPublic FDA data

Application 075009

Type
ANDA
Sponsor
TEVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ETODOLACETODOLACTABLET;ORAL400MGNoNo
002ETODOLACETODOLACTABLET;ORAL500MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-0892EtodolacEtodolacTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0892EtodolacEtodolacTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1893EtodolacEtodolacTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1893EtodolacEtodolacTeva Pharmaceuticals USA, Inc.ANDACurrent
33261-043EtodolacEtodolacAidarex Pharmaceuticals LLCANDACurrent
33261-044EtodolacEtodolacAidarex Pharmaceuticals LLCANDACurrent
35356-826EtodolacEtodolacLake Erie Medical DBA Quality Care Products LLCANDACurrent
42254-052EtodolacEtodolacRebel Distributors CorpANDACurrent
52959-471EtodolacEtodolacH.J. Harkins Company, Inc.ANDACurrent
61919-574ETODOLACETODOLACDIRECT RXANDACurrent
63187-796EtodolacEtodolacProficient Rx LPANDACurrent
63187-796EtodolacEtodolacProficient Rx LPANDACurrent
63629-1377EtodolacEtodolacBryant Ranch PrepackANDACurrent
63629-1377EtodolacEtodolacBryant Ranch PrepackANDACurrent
66336-878EtodolacEtodolacDispensing Solutions, Inc.ANDACurrent
68788-9360EtodolacEtodolacPreferred Pharmaceuticals Inc.ANDACurrent
68788-9928EtodolacEtodolacPreferred Pharmaceuticals, Inc.ANDACurrent
71335-0092EtodolacEtodolacBryant Ranch PrepackANDACurrent
71335-0092EtodolacEtodolacBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
30733SUPPL1999-12-28
30732SUPPL1999-12-28
30731SUPPL1999-12-28
8487SUPPL1999-12-28
8486SUPPL1999-12-28