"27808-189-01" National Drug Code (NDC)

Quetiapine Fumarate 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (27808-189-01)
(Tris Pharma Inc.)

NDC Code27808-189-01
Package Description60 TABLET, EXTENDED RELEASE in 1 BOTTLE (27808-189-01)
Product NDC27808-189
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameQuetiapine Fumarate
Proprietary Name SuffixExtended-release
Non-Proprietary NameQuetiapine Fumarate
Dosage FormTABLET, EXTENDED RELEASE
UsageORAL
Start Marketing Date20191115
Marketing Category NameANDA
Application NumberANDA202939
ManufacturerTris Pharma Inc.
Substance NameQUETIAPINE FUMARATE
Strength400
Strength Unitmg/1
Pharmacy ClassesAtypical Antipsychotic [EPC]

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