"35916-0958-1" National Drug Code (NDC)

Icosapent Ethyl 120 g in 1 BOTTLE (35916-0958-1)
(Softgel Healthcare Private Limited)

NDC Code35916-0958-1
Package Description120 g in 1 BOTTLE (35916-0958-1)
Product NDC35916-0958
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameIcosapent Ethyl
Non-Proprietary NameIcosapent Ethyl Capsules
Dosage FormCAPSULE, LIQUID FILLED
UsageORAL
Start Marketing Date20241202
Marketing Category NameANDA
Application NumberANDA218994
ManufacturerSoftgel Healthcare Private Limited
Substance NameICOSAPENT ETHYL
Strength1
Strength Unitg/g

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