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Details for New Drug Application (NDA): 201109
The generic ingredient in QUETIAPINE FUMARATE is quetiapine fumarate. There are fifty-two drug master file entries for this compound. Fifty-two suppliers are listed for this compound. Additional details are available on the quetiapine fumarate profile page.
Summary for 201109
Tradename: | QUETIAPINE FUMARATE |
Applicant: | Lupin Ltd |
Ingredient: | quetiapine fumarate |
Patents: | 0 |
Therapeutic Class: | Antipsychotics Bipolar Agents |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 201109
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
QUETIAPINE FUMARATE | quetiapine fumarate | TABLET;ORAL | 201109 | ANDA | Lake Erie Medical DBA Quality Care Products LLC | 55700-144 | N | 55700-144-30 |
QUETIAPINE FUMARATE | quetiapine fumarate | TABLET;ORAL | 201109 | ANDA | LUPIN LIMITED | 57297-445 | E | 57297-445-01 |
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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