Details for New Drug Application (NDA): 201504
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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-eight suppliers are listed for this compound. Additional details are available on the quetiapine fumarate profile page.
Summary for 201504
Tradename: | QUETIAPINE FUMARATE |
Applicant: | Alkem Labs Ltd |
Ingredient: | quetiapine fumarate |
Patents: | 0 |
Suppliers and Packaging for NDA: 201504
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
QUETIAPINE FUMARATE | quetiapine fumarate | TABLET;ORAL | 201504 | ANDA | Major Pharmaceuticals | 0904-6638 | 0904-6638-61 | 100 BLISTER PACK in 1 CARTON (0904-6638-61) / 1 TABLET in 1 BLISTER PACK |
QUETIAPINE FUMARATE | quetiapine fumarate | TABLET;ORAL | 201504 | ANDA | Major Pharmaceuticals | 0904-6639 | 0904-6639-61 | 100 BLISTER PACK in 1 CARTON (0904-6639-61) / 1 TABLET in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 25MG BASE | ||||
Approval Date: | Feb 12, 2013 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 50MG BASE | ||||
Approval Date: | Feb 12, 2013 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 100MG BASE | ||||
Approval Date: | Feb 12, 2013 | TE: | AB | RLD: | No |
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