FDA.reportPublic FDA data

Application 091018

Type
ANDA
Sponsor
PAR PHARM INC

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
49884-019Omega-3-Acid Ethyl Estersomega-3-acid ethyl estersPar Pharmaceutical, Inc.ANDACurrent
49884-019Omega-3-Acid Ethyl Estersomega-3-acid ethyl estersPar Pharmaceutical, Inc.ANDACurrent
50090-3956Omega-3-Acid Ethyl Estersomega-3-acid ethyl estersA-S Medication SolutionsANDACurrent
50090-3956Omega-3-Acid Ethyl Estersomega-3-acid ethyl estersA-S Medication SolutionsANDACurrent
50090-3957Omega-3-Acid Ethyl Estersomega-3-acid ethyl estersA-S Medication SolutionsANDACurrent
60429-912Omega-3-Acid Ethyl Estersomega-3-acid ethyl estersGolden State Medical Supply, Inc.ANDACurrent
60429-912Omega-3-Acid Ethyl Estersomega-3-acid ethyl estersGolden State Medical Supply, Inc.ANDACurrent
63629-6805Omega-3-Acid Ethyl Estersomega-3-acid ethyl estersBryant Ranch PrepackANDACurrent
63629-6805Omega-3-Acid Ethyl Estersomega-3-acid ethyl estersBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
50612ORIG2017-12-06