Details for New Drug Application (NDA): 207231
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NDA 207231 describes ILOPERIDONE, which is a drug marketed by Inventia, Lupin Ltd, and Taro, and is included in three NDAs. It is available from one supplier. Additional details are available on the ILOPERIDONE profile page.
The generic ingredient in ILOPERIDONE is iloperidone. There are eight drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the iloperidone profile page.
The generic ingredient in ILOPERIDONE is iloperidone. There are eight drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the iloperidone profile page.
Summary for 207231
| Tradename: | ILOPERIDONE |
| Applicant: | Inventia |
| Ingredient: | iloperidone |
| Patents: | 0 |
Suppliers and Packaging for NDA: 207231
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ILOPERIDONE | iloperidone | TABLET;ORAL | 207231 | ANDA | Mylan Pharmaceuticals Inc. | 0378-0630 | 0378-0630-01 | 100 TABLET in 1 BOTTLE (0378-0630-01) |
| ILOPERIDONE | iloperidone | TABLET;ORAL | 207231 | ANDA | Mylan Pharmaceuticals Inc. | 0378-0630 | 0378-0630-88 | 10 BLISTER PACK in 1 CARTON (0378-0630-88) / 10 TABLET in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
| Approval Date: | Nov 28, 2016 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
| Approval Date: | Nov 28, 2016 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 4MG | ||||
| Approval Date: | Nov 28, 2016 | TE: | RLD: | No | |||||
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