FDA.reportPublic FDA data

Application 075808

Type
ANDA
Sponsor
BARR

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRI-SPRINTECETHINYL ESTRADIOL; NORGESTIMATETABLET;ORAL-280.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0555-9018Tri-Sprintecnorgestimate and ethinyl estradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-9018Tri-Sprintecnorgestimate and ethinyl estradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-9018Tri-Sprintecnorgestimate and ethinyl estradiolTeva Pharmaceuticals USA,ANDACurrent
0555-9018Tri-Sprintecnorgestimate and ethinyl estradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
21695-770Tri-Sprintecnorgestimate and ethinyl estradiolRebel Distributors CorpANDACurrent
63187-458Tri-Sprintecnorgestimate and ethinyl estradiolProficient Rx LPANDACurrent
63187-458Tri-Sprintecnorgestimate and ethinyl estradiolProficient Rx LPANDACurrent
63629-8751Tri-Sprintecnorgestimate and ethinyl estradiolBryant Ranch PrepackANDACurrent
63629-8751Tri-Sprintecnorgestimate and ethinyl estradiolBryant Ranch PrepackANDACurrent
63629-8751Tri-Sprintecnorgestimate and ethinyl estradiolBryant Ranch PrepackANDACurrent
66116-436Tri-Sprintecnorgestimate and ethinyl estradiolMedVantx, Inc.ANDACurrent
68788-6325Tri-Sprintecnorgestimate and ethinyl estradiolPreferred Pharmaceuticals Inc.ANDACurrent
68788-6325Tri-Sprintecnorgestimate and ethinyl estradiolPreferred Pharmaceuticals Inc.ANDACurrent
68788-6325Tri-Sprintecnorgestimate and ethinyl estradiolPreferred Pharmaceuticals Inc.ANDACurrent
68788-6325Tri-Sprintecnorgestimate and ethinyl estradiolPreferred Pharmaceuticals Inc.ANDACurrent
68788-6325Tri-Sprintecnorgestimate and ethinyl estradiolPreferred Pharmaceuticals Inc.ANDACurrent
70518-0842Tri-Sprintecnorgestimate and ethinyl estradiolREMEDYREPACK INC.ANDACurrent
70518-0842Tri-Sprintecnorgestimate and ethinyl estradiolREMEDYREPACK INC.ANDACurrent
70518-0842Tri-Sprintecnorgestimate and ethinyl estradiolREMEDYREPACK INC.ANDACurrent
70518-0842Tri-Sprintecnorgestimate and ethinyl estradiolREMEDYREPACK INC.ANDACurrent
70518-0842Tri-Sprintecnorgestimate and ethinyl estradiolREMEDYREPACK INC.ANDACurrent
70518-0842Tri-Sprintecnorgestimate and ethinyl estradiolREMEDYREPACK INC.ANDACurrent
76413-128Tri-Sprintecnorgestimate and ethinyl estradiolCentral Texas Community Health CentersANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22504ORIG2007-07-06