Details for New Drug Application (NDA): 203359
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NDA 203359 describes QUETIAPINE FUMARATE, which is a drug marketed by Accord Hlthcare, Alignscience Pharma, Amneal Pharms, Aurobindo Pharma, Endo Operations, Intellipharmaceutics, Lupin Ltd, Macleods Pharms Ltd, Novast Labs, Pharmadax Inc, Prinston Inc, Rising, Sciegen Pharms Inc, Unichem, Actavis Grp Ptc, Alembic, Alkem Labs Ltd, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Hetero Labs Ltd V, Hikma, Ipca Labs Ltd, Jubilant Generics, Norvium Bioscience, Sandoz, Sun Pharm, Teva Pharms, and Torrent Pharms Ltd, and is included in thirty-seven NDAs. It is available from fifty 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-one 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-one suppliers are listed for this compound. Additional details are available on the quetiapine fumarate profile page.
Summary for 203359
| Tradename: | QUETIAPINE FUMARATE |
| Applicant: | Macleods Pharms Ltd |
| Ingredient: | quetiapine fumarate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 203359
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| QUETIAPINE FUMARATE | quetiapine fumarate | TABLET;ORAL | 203359 | ANDA | Macleods Pharmaceuticals Limited | 33342-099 | 33342-099-11 | 100 TABLET, FILM COATED in 1 BOTTLE (33342-099-11) |
| QUETIAPINE FUMARATE | quetiapine fumarate | TABLET;ORAL | 203359 | ANDA | Macleods Pharmaceuticals Limited | 33342-099 | 33342-099-12 | 10 BLISTER PACK in 1 CARTON (33342-099-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 25MG BASE | ||||
| Approval Date: | May 17, 2016 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 50MG BASE | ||||
| Approval Date: | May 17, 2016 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 100MG BASE | ||||
| Approval Date: | May 17, 2016 | TE: | AB | RLD: | No | ||||
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