Details for New Drug Application (NDA): 090749
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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 090749
Tradename: | QUETIAPINE FUMARATE |
Applicant: | Hikma |
Ingredient: | quetiapine fumarate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 090749
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
QUETIAPINE FUMARATE | quetiapine fumarate | TABLET;ORAL | 090749 | ANDA | Hikma Pharmaceuticals USA Inc. | 0054-0221 | 0054-0221-20 | 10 BLISTER PACK in 1 CARTON (0054-0221-20) / 10 TABLET in 1 BLISTER PACK |
QUETIAPINE FUMARATE | quetiapine fumarate | TABLET;ORAL | 090749 | ANDA | Hikma Pharmaceuticals USA Inc. | 0054-0221 | 0054-0221-25 | 100 TABLET in 1 BOTTLE (0054-0221-25) |
Profile for product number 001
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 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 100MG 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 200MG BASE | ||||
Approval Date: | Mar 27, 2012 | TE: | AB | RLD: | No |
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