FDA.report

Application 075665

Type
ANDA
Sponsor
TEVA

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001ETODOLACETODOLACTABLET, EXTENDED RELEASE;ORAL600MGNoYes
002ETODOLACETODOLACTABLET, EXTENDED RELEASE;ORAL500MGNoNo
003ETODOLACETODOLACTABLET, EXTENDED RELEASE;ORAL400MGNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-1118EtodolacEtodolacTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1118EtodolacEtodolacTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1118EtodolacEtodolacTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1118EtodolacEtodolacTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1122EtodolacEtodolacTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1122EtodolacEtodolacTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1122EtodolacEtodolacTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1122EtodolacEtodolacTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7172EtodolacEtodolacTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7172EtodolacEtodolacTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7172EtodolacEtodolacTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7172EtodolacEtodolacTeva Pharmaceuticals USA, Inc.ANDACurrent
66336-586EtodolacEtodolacDispensing Solutions, Inc.ANDACurrent
68151-0738EtodolacEtodolacCarilion Materials ManagementANDACurrent
71205-140EtodolacEtodolacProficient Rx LPANDACurrent
71205-140EtodolacEtodolacProficient Rx LPANDACurrent

Documents

DocumentSubmission typeDate
30982SUPPL2001-02-05
30981SUPPL2001-02-05
8755SUPPL2001-02-05
30980ORIG2000-07-31