Details for New Drug Application (NDA): 202152
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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-nine suppliers are listed for this compound. Additional details are available on the quetiapine fumarate profile page.
Summary for 202152
Tradename: | QUETIAPINE FUMARATE |
Applicant: | Accord Hlthcare |
Ingredient: | quetiapine fumarate |
Patents: | 0 |
Suppliers and Packaging for NDA: 202152
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
QUETIAPINE FUMARATE | quetiapine fumarate | TABLET;ORAL | 202152 | ANDA | Northstar RxLLC | 16714-452 | 16714-452-01 | 100 TABLET, FILM COATED in 1 BOTTLE (16714-452-01) |
QUETIAPINE FUMARATE | quetiapine fumarate | TABLET;ORAL | 202152 | ANDA | Northstar RxLLC | 16714-452 | 16714-452-02 | 1000 TABLET, FILM COATED in 1 BOTTLE (16714-452-02) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 25MG BASE | ||||
Approval Date: | Mar 27, 2012 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 50MG BASE | ||||
Approval Date: | Mar 27, 2012 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 100MG BASE | ||||
Approval Date: | Mar 27, 2012 | TE: | AB | RLD: | No |
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