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Details for New Drug Application (NDA): 201109
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NDA 201109 describes QUETIAPINE FUMARATE, which is a drug marketed by Accord Hlthcare, Alignscience Pharma, Amneal Pharms, Anchen Pharms, Aurobindo Pharma Ltd, Intellipharmaceutics, Lupin Ltd, Macleods Pharms Ltd, Novast Labs, Par Pharm, Pharmadax Inc, Sciegen Pharms Inc, Actavis Grp Ptc, Alembic Pharms Ltd, Alkem Labs Ltd, Dr Reddys Labs Ltd, Hikma, Jubilant Generics, Mylan Pharms Inc, Sandoz, Sun Pharm, Teva Pharms, Torrent Pharms Ltd, Unichem Labs Ltd, and Zennova, and is included in thirty-one NDAs. It is available from forty-six suppliers. Additional details are available on the QUETIAPINE FUMARATE profile page.
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.
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 201109
| Tradename: | QUETIAPINE FUMARATE |
| Applicant: | Lupin Ltd |
| Ingredient: | quetiapine fumarate |
| Patents: | 0 |
| 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 | Cardinal Health | 55154-4685 | 55154-4685-0 | 10 BLISTER PACK in 1 BAG (55154-4685-0) > 1 TABLET in 1 BLISTER PACK |
| QUETIAPINE FUMARATE | quetiapine fumarate | TABLET;ORAL | 201109 | ANDA | American Health Packaging | 60687-327 | 60687-327-01 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-327-01) > 1 TABLET in 1 BLISTER PACK (60687-327-11) |
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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