Details for New Drug Application (NDA): 209497
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NDA 209497 describes QUETIAPINE FUMARATE, which is a drug marketed by Accord Hlthcare, Alignscience Pharma, Amneal Pharms, Aurobindo Pharma, Lupin, Macleods Pharms, Novast Labs, Ph Health, Pharmadax, Platinum, Prinston Inc, Rising, Sciegen Pharms, Unichem, Actavis Grp Ptc, Alembic, Alkem Labs Ltd, Aurobindo Pharma Ltd, Chartwell Rx, Hetero Labs Ltd V, Hikma, Ipca Labs Ltd, Jubilant Generics, Lupin Ltd, Pharmobedient, Sun Pharm, Teva Pharms, and Torrent Pharms Ltd, and is included in thirty-eight NDAs. It is available from forty-eight suppliers. Additional details are available on the QUETIAPINE FUMARATE profile page.
The generic ingredient in QUETIAPINE FUMARATE 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 QUETIAPINE FUMARATE 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 209497
| Tradename: | QUETIAPINE FUMARATE |
| Applicant: | Alignscience Pharma |
| Ingredient: | quetiapine fumarate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 209497
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| QUETIAPINE FUMARATE | quetiapine fumarate | TABLET, EXTENDED RELEASE;ORAL | 209497 | ANDA | AlignScience Pharma Inc. | 69948-002 | 69948-002-03 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69948-002-03) |
| QUETIAPINE FUMARATE | quetiapine fumarate | TABLET, EXTENDED RELEASE;ORAL | 209497 | ANDA | AlignScience Pharma Inc. | 69948-002 | 69948-002-11 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69948-002-11) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 150MG BASE | ||||
| Approval Date: | Sep 28, 2018 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 200MG BASE | ||||
| Approval Date: | Sep 28, 2018 | TE: | AB | RLD: | No | ||||
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