Details for New Drug Application (NDA): 020639
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NDA 020639 describes SEROQUEL, which is a drug marketed by Cheplapharm and is included in two NDAs. It is available from two suppliers. Additional details are available on the SEROQUEL profile page.
The generic ingredient in SEROQUEL is quetiapine fumarate. There is one drug master file entry for this compound. Fifty suppliers are listed for this compound. Additional details are available on the quetiapine fumarate profile page.
The generic ingredient in SEROQUEL is quetiapine fumarate. There is one drug master file entry 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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