Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 207420
Company: ASCENT PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OMEGA-3-ACID ETHYL ESTERS OMEGA-3-ACID ETHYL ESTERS 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS CAPSULE;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/25/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

OMEGA-3-ACID ETHYL ESTERS

CAPSULE;ORAL; 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LOVAZA OMEGA-3-ACID ETHYL ESTERS 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS CAPSULE;ORAL Prescription Yes AB 021654 SMITHKLINE BEECHAM
OMEGA-3-ACID ETHYL ESTERS OMEGA-3-ACID ETHYL ESTERS 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS CAPSULE;ORAL Prescription No AB 204940 AMNEAL PHARMS
OMEGA-3-ACID ETHYL ESTERS OMEGA-3-ACID ETHYL ESTERS 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS CAPSULE;ORAL Prescription No AB 090973 APOTEX INC
OMEGA-3-ACID ETHYL ESTERS OMEGA-3-ACID ETHYL ESTERS 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS CAPSULE;ORAL Prescription No AB 207420 ASCENT PHARMS INC
OMEGA-3-ACID ETHYL ESTERS OMEGA-3-ACID ETHYL ESTERS 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS CAPSULE;ORAL Prescription No AB 091018 PAR PHARM INC
OMEGA-3-ACID ETHYL ESTERS OMEGA-3-ACID ETHYL ESTERS 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS CAPSULE;ORAL Prescription No AB 203893 STRIDES PHARMA
OMEGA-3-ACID ETHYL ESTERS OMEGA-3-ACID ETHYL ESTERS 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS CAPSULE;ORAL Prescription No AB 091028 TEVA PHARMS USA
OMEGA-3-ACID ETHYL ESTERS OMEGA-3-ACID ETHYL ESTERS 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS CAPSULE;ORAL Prescription No AB 210107 ZYDUS

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