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Canada
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DRUG PRODUCT COMPOSITIONS
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GDUFA
DMF Review : Complete
Rev. Date : 2014-12-18
Pay. Date : 2014-07-28
DMF Number : 28170
Submission : 2014-03-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26880
Submission : 2013-03-21
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-03
Pay. Date : 2013-12-19
DMF Number : 22100
Submission : 2008-11-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24996
Submission : 2011-05-27
Status : Active
Type : II
Omega-3-acid Triglycerides, SF07200 Or SF08100, ...
Certificate Number : CEP 2007-366 - Rev 03
Status : Valid
Issue Date : 2023-10-06
Type : Chemical
Substance Number : 1352
Omega-3-acid Ethyl Esters 90, RF08000, With Anti...
Certificate Number : R1-CEP 2016-130 - Rev 00
Status : Valid
Issue Date : 2021-08-06
Type : Chemical
Substance Number : 1250
Registration Number : 303MF10027
Registrant's Address : Industrial Park, Xiaohan Town, Deyang, Sichuan, P. R. China
Initial Date of Registration : 2021-02-10
Latest Date of Registration : 2021-02-10
Registration Number : 303MF10016
Registrant's Address : No. 161, South Yinghuashan Road, Shifang, Deyang City, Sichuan, China
Initial Date of Registration : 2021-01-26
Latest Date of Registration : 2021-01-26
Refined fish oil (high in omega-3 fatty acids)
Registrant Name : Aekyung Biopharm Co., Ltd.
Registration Date : 2020-12-04
Registration Number : 6148-2-ND
Manufacturer Name : Aekyung Biopharm Co., Ltd.
Manufacturer Address : 81 Sanggae-ro, Nam-gu, Ulsan Metropolitan City (80, 80A)
Registrant Name : Bibraun Korea Co., Ltd.
Registration Date : 2009-08-21
Registration Number : Su511-1-ND
Manufacturer Name : Croda Europe LTD
Manufacturer Address : Barnfield Road, Leek Staffordshire ST13 5QJ, UK (Cowick Hall, Snaith, Goole, East Yor...
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Details:
Under the terms of the agreement Nuvothera has acquired an option to exclusively licence rights to develop and commercialise EPADILIN® in the United States.
Lead Product(s): Omega-3,Omega 6
Therapeutic Area: Dermatology Brand Name: Epadilin
Study Phase: Approved FDFProduct Type: Vitamins/Minerals/Inorganic Salts
Sponsor: Nuvothera
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement March 18, 2021
Lead Product(s) : Omega-3,Omega 6
Therapeutic Area : Dermatology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Nuvothera
Deal Size : Undisclosed
Deal Type : Licensing Agreement
DS Biopharma and Nuvothera Enter Option and License Agreement for EPADILIN®
Details : Under the terms of the agreement Nuvothera has acquired an option to exclusively licence rights to develop and commercialise EPADILIN® in the United States.
Product Name : Epadilin
Product Type : Vitamins/Minerals/Inorganic Salts
Upfront Cash : Undisclosed
March 18, 2021
Details:
Acasti Pharma plans to seek FDA guidance prior to unblinding TRILOGY 2 data, which is expected to delay reporting of TRILOGY 2 topline results until calendar Q3, 2020.
Lead Product(s): Omega-3
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Vitamins/Minerals/Inorganic Salts
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 02, 2020
Lead Product(s) : Omega-3
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Acasti Pharma Provides Update on TRILOGY 1 and TRILOGY 2 Phase 3
Details : Acasti Pharma plans to seek FDA guidance prior to unblinding TRILOGY 2 data, which is expected to delay reporting of TRILOGY 2 topline results until calendar Q3, 2020.
Product Name : Undisclosed
Product Type : Vitamins/Minerals/Inorganic Salts
Upfront Cash : Inapplicable
October 02, 2020
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Nutriflex Omega Plus
Dosage Form : INF
Dosage Strength : 4g/1000ml
Packaging : 1250X1g/1000ml
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Nutriflex Omega Specialized
Dosage Form : INF
Dosage Strength : 4g/1000ml
Packaging : 1250X1g/1000ml
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info :
Registration Country : Ukraine
Omega-3; Ascorbic Acid; Vitamin E; Lutein; Zinc Oxide; zeaxanthin; Copper Sulfate
Brand Name : VisiloTON complex
Dosage Form : Capsule
Dosage Strength :
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Ukraine
Regulatory Info :
Registration Country : Ukraine
Brand Name : Epadol Neo
Dosage Form : Soft Capsule
Dosage Strength : 1000MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Ukraine
Regulatory Info :
Registration Country : Norway
Brand Name : Omacor
Dosage Form : Kapsel, myk
Dosage Strength : 1000 mg
Packaging : Boks av plast 100item
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Spain
Brand Name : Omega 3 Aristo 1000Mg 100 Softgels (250Ml) Efg
Dosage Form : Softgels
Dosage Strength : 1000 Mg/Softgels
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Spain
Brand Name : Omega 3 Kern Pharma 1,000Mg 100 Softgels Efg
Dosage Form : Softgels
Dosage Strength : 1000 Mg/Softgels
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Spain
Brand Name : Omacor 1000Mg 100 Softgels
Dosage Form : Softgels
Dosage Strength : 1000 Mg/Softgels
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Spain
Brand Name : Omega 3 Strides 1000Mg 100 Softgels Efg
Dosage Form : Softgels
Dosage Strength : 1000 Mg/Softgels
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Spain
Brand Name : Omega 3 Ratiopharm 1000Mg 28 Softgels (Bottle) Efg
Dosage Form : Softgels
Dosage Strength : 1000 Mg/Softgels
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Norway
Brand Name : Omacor
Dosage Form : Kapsel, myk
Dosage Strength : 1000 mg
Packaging : Boks av plast 100item
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Spain
Brand Name : Omega 3 Aristo 1000Mg 100 Softgels (250Ml) Efg
Dosage Form : Softgels
Dosage Strength : 1000 Mg/Softgels
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Spain
Brand Name : Omega 3 Teva 1000Mg 100 Softgels (Bottle) Efg
Dosage Form : Softgels
Dosage Strength : 1000 Mg/Softgels
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Spain
Brand Name : Omega 3 Kern Pharma 1,000Mg 100 Softgels Efg
Dosage Form : Softgels
Dosage Strength : 1000 Mg/Softgels
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Spain
Brand Name : Omacor 1000Mg 100 Softgels
Dosage Form : Softgels
Dosage Strength : 1000 Mg/Softgels
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Spain
Brand Name : Omega 3 Tarbis 1000Mg 100 Softgels Efg
Dosage Form : Softgels
Dosage Strength : 1000 Mg/Softgels
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Spain
Brand Name : Omega 3 Ratiopharm 1000Mg 28 Softgels (Bottle) Efg
Dosage Form : Softgels
Dosage Strength : 1000 Mg/Softgels
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Spain
Brand Name : Omega 3 Stada 1000Mg 28 Softgels Efg
Dosage Form : Softgels
Dosage Strength : 1000 Mg/Softgels
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Spain
Brand Name : Omega 3 Aristo 1000Mg 28 Softgels (75Ml) Efg
Dosage Form : Softgels
Dosage Strength : 1000 Mg/Softgels
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Spain
Brand Name : Omega 3 Teva 1000Mg 28 Softgels (Bottle) Efg
Dosage Form : Softgels
Dosage Strength : 1000 Mg/Softgels
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Nutriflex Omega Plus
Dosage Form : INF
Dosage Strength : 4g/1000ml
Packaging : 1250X1g/1000ml
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Nutriflex Omega Plus
Dosage Form : INF
Dosage Strength : 4g/1000ml
Packaging : 1875X1g/1000ml
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Nutriflex Omega Specialized
Dosage Form : INF
Dosage Strength : 4g/1000ml
Packaging : 625X1g/1000ml
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Nutriflex Omega Specialized
Dosage Form : INF
Dosage Strength : 4g/1000ml
Packaging : 1250X1g/1000ml
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Nutriflex Omega Specialized
Dosage Form : INF
Dosage Strength : 4g/1000ml
Packaging : 1875X1g/1000ml
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info :
Registration Country : Ukraine
Brand Name : Epadol Neo
Dosage Form : Soft Capsule
Dosage Strength : 1000MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Ukraine
Packaging :
Regulatory Info :
Dosage : Soft Capsule
Dosage Strength : 1000MG
Brand Name : Epadol Neo
Approval Date :
Application Number :
Registration Country : Ukraine
Related Excipient Companies
Dosage Form : Tablet
Grade : Oral
Dosage Form : Cream / Lotion / Ointment
Grade : Topical, Parenteral
Dosage Form : Capsule
Grade : Oral
Application : Solubilizers
Excipient Details : L-Lysine acetate is used as a solubilizer in capsules along with other oral solid dosage forms.
Pharmacopoeia Ref : NA
Technical Specs : Molecular weight: 206.24 g/mol
Ingredient(s) : L-Lysine Acetate
Dosage Form : Tablet
Grade : Oral
Dosage Form : Suspension
Grade : Oral
Dosage Form : Capsule
Grade : Oral
Dosage Form : Tablet
Grade : Oral
Dosage Form : Softgels
Grade : Oral
Excipients by Applications
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