Details for New Drug Application (NDA): 210093

NDA 210093 describes OMEGA-3-ACID ETHYL ESTERS, which is a drug marketed by Amneal Pharms, Apotex, Ascent Pharms Inc, Bionpharma, Cspc-nbp Pharm, GLW, Mankind Pharma, Puracap Pharm Llc, Slayback Pharma Llc, Sofgen Pharms, Strides Pharma, Sun Pharm, and Zydus, and is included in fifteen NDAs. It is available from twenty-two suppliers. Additional details are available on the OMEGA-3-ACID ETHYL ESTERS profile page.

The generic ingredient in OMEGA-3-ACID ETHYL ESTERS is omega-3-acid ethyl esters. There are thirteen drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the omega-3-acid ethyl esters profile page.

Summary for 210093

Tradename:	OMEGA-3-ACID ETHYL ESTERS
Applicant:	Puracap Pharm Llc
Ingredient:	omega-3-acid ethyl esters
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 210093

Suppliers and Packaging for NDA: 210093

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OMEGA-3-ACID ETHYL ESTERS	omega-3-acid ethyl esters	CAPSULE;ORAL	210093	ANDA	PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS	24658-350	24658-350-12	120 CAPSULE, LIQUID FILLED in 1 BOTTLE (24658-350-12)
OMEGA-3-ACID ETHYL ESTERS	omega-3-acid ethyl esters	CAPSULE;ORAL	210093	ANDA	EPIC PHARMA, LLC	42806-552	42806-552-12	120 CAPSULE, LIQUID FILLED in 1 BOTTLE (42806-552-12)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS
Approval Date:	Jun 15, 2020	TE:	AB	RLD:	No

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