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, Chartwell, Cspc-nbp Pharm, GLW, Mankind Pharma, Puracap Pharm Llc, Sofgen Pharms, Strides Pharma, Sun Pharm, Wilshire Pharms Inc, and Zydus Lifesciences, 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

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	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8550	0615-8550-39	30 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0615-8550-39)
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)

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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