Details for New Drug Application (NDA): 211405
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The generic ingredient in QUETIAPINE FUMARATE is quetiapine fumarate. There are fifty-three drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the quetiapine fumarate profile page.
Summary for 211405
Tradename: | QUETIAPINE FUMARATE |
Applicant: | Amneal Pharms |
Ingredient: | quetiapine fumarate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 211405
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
QUETIAPINE FUMARATE | quetiapine fumarate | TABLET, EXTENDED RELEASE;ORAL | 211405 | ANDA | Amneal Pharmaceuticals LLC | 65162-431 | 65162-431-06 | 60 TABLET, FILM COATED in 1 BOTTLE (65162-431-06) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 400MG BASE | ||||
Approval Date: | Oct 26, 2018 | TE: | RLD: | No |
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