Details for New Drug Application (NDA): 022047
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NDA 022047 describes SEROQUEL XR, which is a drug marketed by Cheplapharm and is included in one NDA. It is available from two suppliers. Additional details are available on the SEROQUEL XR profile page.
The generic ingredient in SEROQUEL XR 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 XR 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 022047
| Tradename: | SEROQUEL XR |
| Applicant: | Cheplapharm |
| Ingredient: | quetiapine fumarate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 022047
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SEROQUEL XR | quetiapine fumarate | TABLET, EXTENDED RELEASE;ORAL | 022047 | NDA | AstraZeneca Pharmaceuticals LP | 0310-0281 | 0310-0281-60 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (0310-0281-60) |
| SEROQUEL XR | quetiapine fumarate | TABLET, EXTENDED RELEASE;ORAL | 022047 | NDA | AstraZeneca Pharmaceuticals LP | 0310-0282 | 0310-0282-60 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (0310-0282-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 50MG BASE | ||||
| Approval Date: | May 17, 2007 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 200MG BASE | ||||
| Approval Date: | May 17, 2007 | TE: | AB | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 300MG BASE | ||||
| Approval Date: | May 17, 2007 | TE: | AB | RLD: | Yes | ||||
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