Details for New Drug Application (NDA): 090681
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NDA 090681 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 forty-seven 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 090681
| Tradename: | QUETIAPINE FUMARATE |
| Applicant: | Accord Hlthcare |
| Ingredient: | quetiapine fumarate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 090681
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| QUETIAPINE FUMARATE | quetiapine fumarate | TABLET, EXTENDED RELEASE;ORAL | 090681 | ANDA | Accord Healthcare Inc. | 16729-095 | 16729-095-12 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-095-12) |
| QUETIAPINE FUMARATE | quetiapine fumarate | TABLET, EXTENDED RELEASE;ORAL | 090681 | ANDA | Accord Healthcare Inc. | 16729-096 | 16729-096-12 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-096-12) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 150MG BASE | ||||
| Approval Date: | May 9, 2017 | 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: | May 9, 2017 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 300MG BASE | ||||
| Approval Date: | May 9, 2017 | TE: | AB | RLD: | No | ||||
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