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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204940
Company: AMNEAL PHARMS
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
11/27/2015 ORIG-1 Approval STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/06/2021 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

02/24/2020 SUPPL-7 Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert

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 WOODWARD
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
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 206455 BIONPHARMA 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 211979 CSPC-NBP PHARM
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 GLW
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 212504 GLW
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 215458 MANKIND 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 210093 PURACAP PHARM LLC
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 211355 SOFGEN 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 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 210834 SUN PHARM
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