Details for New Drug Application (NDA): 020639
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The generic ingredient in SEROQUEL is quetiapine fumarate. There are fifty-three drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the quetiapine fumarate profile page.
Summary for 020639
| Tradename: | SEROQUEL |
| Applicant: | Cheplapharm |
| Ingredient: | quetiapine fumarate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 020639
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SEROQUEL | quetiapine fumarate | TABLET;ORAL | 020639 | NDA | AstraZeneca Pharmaceuticals LP | 0310-0271 | 0310-0271-10 | 100 TABLET, FILM COATED in 1 BOTTLE (0310-0271-10) |
| SEROQUEL | quetiapine fumarate | TABLET;ORAL | 020639 | NDA | AstraZeneca Pharmaceuticals LP | 0310-0272 | 0310-0272-10 | 100 TABLET, FILM COATED in 1 BOTTLE (0310-0272-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 25MG BASE | ||||
| Approval Date: | Sep 26, 1997 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 100MG BASE | ||||
| Approval Date: | Sep 26, 1997 | TE: | AB | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 200MG BASE | ||||
| Approval Date: | Sep 26, 1997 | TE: | AB | RLD: | Yes | ||||
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