Omega-3 carboxylic acids Oral Capsule

Brand(s)
Epanova
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Astrazeneca Pharmaceuticals Lp (2014-09-08)
Oldest Current Product
2015-06-01
License(s)
NDA
RxNORM
ORAL CAPSULE\OMEGA-3 CARBOXYLIC ACIDS
FDAOB
ORAL\CAPSULE\OMEGA-3-CARBOXYLIC ACIDS
SPL Active
ORAL\CAPSULE, GELATIN COATED\OMEGA-3-CARBOXYLIC ACIDS
SPL Moiety
ORAL\CAPSULE, GELATIN COATED\OMEGA-3-CARBOXYLIC ACIDS

product(s) by strength(s)

omega-3 carboxylic acids 1000 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003102222EpanovaNDAAstrazeneca Pharmaceuticals Lp2015-06-01OMEGA-3-CARBOXYLIC ACIDSORALCAPSULE, GELATIN COATEDNDA205060fa00cfaa-6ec9-4022-a01b-9daddf6ddfeb

application(s)

#idtitleapplicantapprovedpatentapproved drug
1NDA205060EPANOVAASTRAZENECA PHARMACEUTICALS LP2014-05-05p7960370, SUBSTANCE
p9050309
p9050308, TREATMENT OF HYPERTRIGLYCERIDEMIA
p5792795, SUBSTANCE
p9132112, TREATMENT OF HYPERTRIGLYCERIDEMIA , SUBSTANCE
p5948818, SUBSTANCE
p9012501, TREATMENT OF HYPERTRIGLYCERIDEMIA , SUBSTANCE
p8383678, TREATMENT OF HYPERTRIGLYCERIDEMIA , SUBSTANCE
NDA205060_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA205060_001RXOMEGA-3-CARBOXYLIC ACIDS (1GM CONTAINS AT LEAST 850MG OF POLYUNSATURATED FATTY ACIDS)ORALCAPSULETrue2014-05-05EPANOVA

patent(s)

#idexpiration dateapplication(s)
1p5792795 (view patent)2016-05-13NDA205060
2p5948818 (view patent)2016-05-13NDA205060
3p7960370 (view patent)2025-02-07NDA205060
4p8383678 (view patent)2025-02-07NDA205060
5p9012501 (view patent)2025-02-07NDA205060
6p9050308 (view patent)2033-01-04NDA205060
7p9050309 (view patent)2033-01-04NDA205060
8p9132112 (view patent)2025-02-07NDA205060

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1fa00cfaa-6ec9-4022-a01b-9daddf6ddfeb (view SPL)These highlights do not include all the information needed to use EPANOVA safely and effectively. See full prescribing information for EPANOVA. EPANOVA (omega-3-carboxylic acids) capsules, for oral useInitial U.S. Approval: 2014prescriptionHuman PrescriptionAstrazeneca Pharmaceuticals Lp2014-09-084003102222

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII