Details for New Drug Application (NDA): 206954
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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-seven suppliers are listed for this compound. Additional details are available on the quetiapine fumarate profile page.
Summary for 206954
Tradename: | QUETIAPINE FUMARATE |
Applicant: | Prinston Inc |
Ingredient: | quetiapine fumarate |
Patents: | 0 |
Suppliers and Packaging for NDA: 206954
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
QUETIAPINE FUMARATE | quetiapine fumarate | TABLET;ORAL | 206954 | ANDA | Solco Healthcare US, LLC | 43547-518 | 43547-518-10 | 100 TABLET in 1 BOTTLE (43547-518-10) |
QUETIAPINE FUMARATE | quetiapine fumarate | TABLET;ORAL | 206954 | ANDA | Solco Healthcare US, LLC | 43547-518 | 43547-518-11 | 1000 TABLET in 1 BOTTLE (43547-518-11) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 25MG BASE | ||||
Approval Date: | Aug 24, 2022 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 50MG BASE | ||||
Approval Date: | Aug 24, 2022 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 100MG BASE | ||||
Approval Date: | Aug 24, 2022 | TE: | AB | RLD: | No |
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