FDA
Icosapent Ethyl
The FDA lists this product in 18 strengths and forms.
Composition
- Active ingredients
- ICOSAPENT ETHYL 1GM
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- ICOSAPENT ETHYL 1GM · CapsuleANDA209457-001 · Prescription
- ICOSAPENT ETHYL 500MG · CapsuleANDA209457-002 · Prescription
- ICOSAPENT ETHYL 1GM · CapsuleANDA209437-001 · Prescription
- ICOSAPENT ETHYL 1GM · CapsuleANDA216811-002 · Prescription
- ICOSAPENT ETHYL 500MG · CapsuleANDA216811-001 · Prescription
- ICOSAPENT ETHYL 500MG · CapsuleANDA217919-001 · Prescription
- ICOSAPENT ETHYL 1GM · CapsuleANDA217919-002 · Prescription
- ICOSAPENT ETHYL 1GM · CapsuleANDA218994-001 · Prescription
- ICOSAPENT ETHYL 1GM · CapsuleANDA209499-001 · Prescription
- ICOSAPENT ETHYL 500MG · CapsuleANDA209499-002 · Prescription
- ICOSAPENT ETHYL 500MG · CapsuleANDA217656-001 · Prescription
- ICOSAPENT ETHYL 1GM · CapsuleANDA217656-002 · Prescription
- ICOSAPENT ETHYL 1GM · Capsule
At a glance
- Brand name
- Icosapent Ethyl
- Route
- Oral
- Dosage form
- Capsule
- Applicant
- Onesource Specialty
- Status
- Prescription
- FDA approval
- 22 Sept 2023
- Application
- ANDA217844-002