Details for New Drug Application (NDA): 203390
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NDA 203390 describes QUETIAPINE FUMARATE, which is a drug marketed by Accord Hlthcare, Alignscience Pharma, Amneal Pharms, Aurobindo Pharma, Lupin Ltd, Macleods Pharms Ltd, Medicap Labs, Novast Labs, Ph Health, Pharmadax Inc, Prinston Inc, Rising, Sciegen Pharms Inc, Unichem, Actavis Grp Ptc, Alembic, Alkem Labs Ltd, Aurobindo Pharma Ltd, Chartwell Rx, Hetero Labs Ltd V, Hikma, Ipca Labs Ltd, Jubilant Generics, 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 are fifty-three drug master file entries 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 are fifty-three drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the quetiapine fumarate profile page.
Summary for 203390
| Tradename: | QUETIAPINE FUMARATE |
| Applicant: | Alembic |
| Ingredient: | quetiapine fumarate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 203390
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| QUETIAPINE FUMARATE | quetiapine fumarate | TABLET;ORAL | 203390 | ANDA | Alembic Pharmaceuticals Limited | 46708-134 | 46708-134-10 | 100 TABLET, FILM COATED in 1 CARTON (46708-134-10) |
| QUETIAPINE FUMARATE | quetiapine fumarate | TABLET;ORAL | 203390 | ANDA | Alembic Pharmaceuticals Limited | 46708-134 | 46708-134-30 | 30 TABLET, FILM COATED in 1 BOTTLE (46708-134-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 25MG BASE | ||||
| Approval Date: | Oct 28, 2014 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 50MG BASE | ||||
| Approval Date: | Oct 28, 2014 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 100MG BASE | ||||
| Approval Date: | Oct 28, 2014 | TE: | RLD: | No | |||||
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