Details for New Drug Application (NDA): 202674
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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 202674
Tradename: | QUETIAPINE FUMARATE |
Applicant: | Unichem |
Ingredient: | quetiapine fumarate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 202674
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
QUETIAPINE FUMARATE | quetiapine fumarate | TABLET;ORAL | 202674 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8470 | 0615-8470-05 | 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8470-05) |
QUETIAPINE FUMARATE | quetiapine fumarate | TABLET;ORAL | 202674 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8470 | 0615-8470-39 | 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8470-39) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 25MG BASE | ||||
Approval Date: | Mar 8, 2016 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 50MG BASE | ||||
Approval Date: | Mar 8, 2016 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 100MG BASE | ||||
Approval Date: | Mar 8, 2016 | TE: | AB | RLD: | No |
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