FDA.reportPublic FDA data

Application 091028

Type
ANDA
Sponsor
TEVA PHARMS USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OMEGA-3-ACID ETHYL ESTERSOMEGA-3-ACID ETHYL ESTERSCAPSULE;ORAL1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-5401Omega-3-Acid Ethyl EstersOmega-3-Acid Ethyl EstersTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5401Omega-3-Acid Ethyl EstersOmega-3-Acid Ethyl EstersTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5401Omega-3-Acid Ethyl EstersOmega-3-Acid Ethyl EstersTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5401Omega-3-Acid Ethyl EstersOmega-3-Acid Ethyl EstersTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5401Omega-3-Acid Ethyl EstersOmega-3-Acid Ethyl EstersTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5401Omega-3-Acid Ethyl EstersOmega-3-Acid Ethyl EstersTeva Pharmaceuticals USA, Inc.ANDACurrent
42708-067Omega-3-Acid Ethyl EstersOmega-3-Acid Ethyl EstersQPharma IncANDACurrent
42708-067Omega-3-Acid Ethyl EstersOmega-3-Acid Ethyl EstersQPharma IncANDACurrent
42708-067Omega-3-Acid Ethyl EstersOmega-3-Acid Ethyl EstersQPharma IncANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
50613ORIG2017-12-06