DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 201109
NDA 201109 describes QUETIAPINE FUMARATE, which is a drug marketed by Accord Hlthcare, Anchen Pharms, Aurobindo Pharma Ltd, Intellipharmaceutics, Lupin Ltd, Macleods Pharms Ltd, Novast Labs Ltd, Par Pharm, Pharmadax Inc, Sciegen Pharms Inc, Actavis Grp Ptc, Alembic Pharms Ltd, Alkem Labs Ltd, Apotex Inc, Dr Reddys Labs Ltd, Jubilant Generics, Mylan Pharms Inc, Sandoz, Sun Pharma Global, Teva Pharms, Torrent Pharms Ltd, Unichem Labs Ltd, and West-ward Pharms Int, and is included in twenty-nine 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 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.
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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