FISH OIL
- First approval year
- 2016
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Unknown
- Drug name
- FISH OIL
- b1782
- B1782
- fish oil
- Fish oil
- Fish Oil (Containing Omega-3 Acids)
- fish oil (FO)-containing IVFE (Lipidem)
- Fish oil (Maxepa)
- FISH OIL [ORANGE BOOK]
- FISH OIL [USP-RS]
- FISH OIL [VANDF]
- Fish oil [WHO-DD]
- Fish oil concentrate
- fish oil containing omega 3 acids
- fish oil containing omega 3 acids dsc
- FISH OIL CONTAINING OMEGA-3 ACIDS [DSC]
- fish oil fo containing ivfe lipidem
- fish oil orange book
- fish oil usp rs
- fish oil vandf
- fish oil who dd
- Fish oil-containing total parenteral nutrition (PN)
- fish oils
- Fish oils
- FISH OILS
- omega 3 fish oil
And 3 more, listed on the interactive page.
- Applicant
- FRESENIUS KABI USA
- Approval date
- 13 Jul 2016
- Application number
- NDA207648
- First in class
- No
- Orphan designation
- No
- Availability
- Prescription only
Administration routes
- Parenteral
- Condition
- Cardiovascular Diseases
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000319
- Subject identifier
- D002318
- Condition
- Epilepsy
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000474
- Subject identifier
- D004827
- Condition
- Arthritis, Rheumatoid
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000685
- Subject identifier
- D001172
- Condition
- Obesity
- Highest recorded phase
- 3
- Condition identifier
- EFO:0001073
- Subject identifier
- D009765
- Condition
- Liver Diseases
- Highest recorded phase
- 2
- Condition identifier
- EFO:0001421
- Subject identifier
- D008107
- Condition
- Coronary Disease
- Highest recorded phase
- 3
- Condition identifier
- EFO:0001645
- Subject identifier
- D003327
- Condition
- Kidney Diseases
- Highest recorded phase
- 0.5
- Condition identifier
- EFO:0003086
- Subject identifier
- D007674
- Condition
- Non-alcoholic Fatty Liver Disease
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003095
- Subject identifier
- D065626
- Condition
- Renal Insufficiency, Chronic
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003884
- Subject identifier
- D051436
- Condition
- Intestinal Diseases
- Highest recorded phase
- 3
- Condition identifier
- EFO:0009431
- Subject identifier
- D007410
- Condition
- Brain Concussion
- Highest recorded phase
- 2
- Condition identifier
- EFO:0011023
- Subject identifier
- D001924
- Condition
- Aging
- Highest recorded phase
- 1
- Condition identifier
- EFO:0022597
- Subject identifier
- D000375
- Condition
- Diabetic Neuropathies
- Highest recorded phase
- 1
- Condition identifier
- EFO:1000783
- Subject identifier
- D003929
- Condition
- Phobia, Social
- Highest recorded phase
- 2
- Condition identifier
- EFO:1001917
- Subject identifier
- D000072861
- Condition
- Fatty Liver
- Highest recorded phase
- 2
- Condition identifier
- HP:0001397
- Subject identifier
- D005234
- Condition
- Cholestasis
- Highest recorded phase
- 3
- Condition identifier
- MONDO:0001751
- Subject identifier
- D002779
- Condition
- Depressive Disorder, Major
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0002009
- Subject identifier
- D003865
- Condition
- Depressive Disorder
- Highest recorded phase
- 3
- Condition identifier
- MONDO:0002050
- Subject identifier
- D003866
- Condition
- Asthma
- Highest recorded phase
- 3
- Condition identifier
- MONDO:0004979
- Subject identifier
- D001249
- Condition
- Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0004992
- Subject identifier
- D009369
- Condition
- Multiple Sclerosis
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0005301
- Subject identifier
- D009103
- Condition
- Breast Neoplasms
- Highest recorded phase
- 0.5
- Condition identifier
- MONDO:0007254
- Subject identifier
- D001943
- Condition
- Lupus Erythematosus, Systemic
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0007915
- Subject identifier
- D008180
- Condition
- Inflammation
- Highest recorded phase
- 2
- Condition identifier
- MP:0001845
- Subject identifier
- D007249
- Condition
- Lipid Metabolism Disorders
- Highest recorded phase
- 3
- Condition identifier
- Orphanet:309005
- Subject identifier
- D052439
- Condition identifier
- EFO_0000195
- Condition identifier
- EFO_0000246
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000319
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000474
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000685
- Highest recorded phase
- 3
- Condition identifier
- EFO_0001073
- Highest recorded phase
- 3
- Condition identifier
- EFO_0003095
- Condition identifier
- EFO_0004278
- Highest recorded phase
- 2
- Condition identifier
- EFO_0009431
- Highest recorded phase
- 3
- Condition identifier
- EFO_0011023
- Highest recorded phase
- 2
- Condition identifier
- EFO_0022597
- Highest recorded phase
- 3
- Condition identifier
- EFO_1000653
- Condition identifier
- EFO_1000783
- Condition identifier
- EFO_1001917
- Highest recorded phase
- 2
- Condition identifier
- GO_0006954
- Highest recorded phase
- 2
- Condition identifier
- HP_0000155
- Highest recorded phase
- 2
- Condition identifier
- HP_0000458
- Highest recorded phase
- 2
- Condition identifier
- HP_0000739
- Highest recorded phase
- 2
- Condition identifier
- HP_0000855
- Highest recorded phase
- 3
- Condition identifier
- HP_0001397
- Condition identifier
- HP_0001824
- Highest recorded phase
- 2
- Condition identifier
- HP_0002019
- Condition identifier
- HP_0002032
- Highest recorded phase
- 2
- Condition identifier
- HP_0004308
- Highest recorded phase
- 2
- Condition identifier
- HP_0004326
- Highest recorded phase
- 2
And 43 more, listed on the interactive page.
- Event
- angina pectoris
- Reports
- 31
- Reporting signal score
- 40.2418
- Event
- arteriogram coronary
- Reports
- 24
- Reporting signal score
- 143.78
- Event
- bacillus bacteraemia
- Reports
- 3
- Reporting signal score
- 16.3745
- Event
- blood triglycerides increased
- Reports
- 43
- Reporting signal score
- 90.6745
- Event
- cataract
- Reports
- 28
- Reporting signal score
- 30.1549
- Event
- chest pain
- Reports
- 56
- Reporting signal score
- 26.1366
- Event
- child abuse
- Reports
- 5
- Reporting signal score
- 25.63
- Event
- cholestasis
- Reports
- 15
- Reporting signal score
- 24.043
- Event
- coma
- Reports
- 101
- Reporting signal score
- 203.937
- Event
- diabetic retinal oedema
- Reports
- 4
- Reporting signal score
- 15.1824
- Event
- drug hypersensitivity
- Reports
- 34
- Reporting signal score
- 15.5546
- Event
- dysgeusia
- Reports
- 29
- Reporting signal score
- 24.8962
- Event
- eructation
- Reports
- 24
- Reporting signal score
- 59.2773
- Event
- fatty acid deficiency
- Reports
- 34
- Reporting signal score
- 231.494
- Event
- gastrooesophageal reflux disease
- Reports
- 103
- Reporting signal score
- 197.433
- Event
- hernia
- Reports
- 21
- Reporting signal score
- 41.9303
- Event
- hernial eventration
- Reports
- 6
- Reporting signal score
- 28.4742
- Event
- hypertriglyceridaemia
- Reports
- 17
- Reporting signal score
- 32.5478
- Event
- infectious mononucleosis
- Reports
- 7
- Reporting signal score
- 22.8174
- Event
- lactobacillus infection
- Reports
- 3
- Reporting signal score
- 15.3908
- Event
- lactobacillus test positive
- Reports
- 4
- Reporting signal score
- 23.9996
- Event
- malassezia infection
- Reports
- 3
- Reporting signal score
- 19.4272
- Event
- multiple lentigines syndrome
- Reports
- 4
- Reporting signal score
- 25.5389
- Event
- neoplasm
- Reports
- 13
- Reporting signal score
- 23.6923
- Event
- pantoea agglomerans infection
- Reports
- 3
- Reporting signal score
- 17.8501
And 12 more, listed on the interactive page.
- NCT00047983
- NCT00072982
- NCT00336908
- NCT00392717
- NCT00447291
- NCT00485615
- NCT00511810
- NCT00516178
- NCT00655525
- NCT00658476
- NCT00711971
- NCT00681408
- NCT01547910
- NCT00871377
- NCT01769092
- NCT01057615
- NCT05613803
- NCT01194063
- NCT02420496
- NCT01259284
- NCT02021513
- NCT02178410
- NCT02538484
- NCT02550860
- NCT02939079
And 3 more, listed on the interactive page.
- Dose
- 1 capsule
- Route
- Oral
- How often
- Once daily
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- 63323-205
- 63323-820
Related records
Trials (97)
- A Fish Oil Supplement to Maintain Body Weight in Patients With Disease-Related Weight Loss
- A Phase II Randomized Trial of Fish Oil in Patients With Acute Lung Injury (ALI)
- A Pilot Study of Fish Oil Supplementation in Hemodialysis Patients
- A Pilot Study to Assess the Efficacy and Safety of LCQ908 Alone and in Combination With Fenofibrate or Lovaza® in Patients With Severe Hypertriglyceridemia
- A Study of the Effect of Gemcitabine With Fish Oil in Patients With Advanced Pancreatic Cancer
- A Study of the Pharmacokinetics and Immunologic Effects of Lipoic Acid in Multiple Sclerosis
- A Study to Determine Optimal Absorption of Single Dose Omega-3
- Cancer Lipidome Adaptation and Resculping Through Omega-3 PUFAs in Breast Tumors
- Comparison of EPA and DHA-Rich Fish Oils on Lipoprotein Metabolism In Adults
- COVID-19 Anosmia Study
- Deep-sea Fish Oil for Prevention of Acute Radiation-induced Esophagitis
- Derivatives of Omega-3 HUFA as Biomarkers of Traumatic Brain Injury
- Dietary Fish Oil Intervention in Polycystic Ovary Syndrome (PCOS)
- Dietary Supplementation With Omega-3 Fatty Acid in Muscle Response
- Does Fish Oil Prevent Depression in Pregnancy and Postpartum?
- Effect of Dietary Supplements With Fish Oil on Mannitol-induced Airway Sensitivity & Inflammation in Persons With Asthma
- Effect of Fish Oil on Adiposity and Atherogenic Factors in Type 2 Diabetic Women
- Effect of Lipid Lowering Agents on Diabetic Retinopathy and Cardiovascular Risk of Diabetic Patients
- Effect of Omega-3 Fatty Acid on Neurobehavioral Status of Children With Autism Spectrum Disorder: A Randomized, Double-Blind, Placebo Controlled Trial
- Effect of Omega-3 Fatty Acid on Vitamin D Activation
In development for (22)
- Asthma Phase 3
- Breast cancer Early phase 1
- Cancer Phase 2
- Cardiovascular disorder Phase 3
- Cholestasis Phase 3
- Chronic kidney disease Phase 2
- Coronary artery disorder Phase 3
- Depressive disorder Phase 3
- Diabetic neuropathy Phase 1
- Epilepsy Phase 2
- Fatty liver disease Phase 2
- Inherited lipid metabolism disorder Phase 3
- Intestinal disorder Phase 3
- Kidney disorder Early phase 1
- Liver disorder Phase 2
- Major depressive disorder Phase 2
- Metabolic dysfunction-associated steatotic liver disease Phase 2
- Multiple sclerosis Phase 2
- Obesity disorder Phase 3
- Rheumatoid arthritis Phase 3