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Details for New Drug Application (NDA): 207098
» See Plans and Pricing
NDA 207098 describes ILOPERIDONE, which is a drug marketed by Inventia and Taro Pharm Inds Ltd and is included in two 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 207098
| Tradename: | ILOPERIDONE |
| Applicant: | Taro Pharm Inds Ltd |
| Ingredient: | iloperidone |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 207098
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ILOPERIDONE | iloperidone | TABLET;ORAL | 207098 | ANDA | Taro Pharmaceuticals U.S.A., Inc. | 51672-4178 | 51672-4178-4 | 60 TABLET in 1 BOTTLE (51672-4178-4) |
| ILOPERIDONE | iloperidone | TABLET;ORAL | 207098 | ANDA | Taro Pharmaceuticals U.S.A., Inc. | 51672-4179 | 51672-4179-4 | 60 TABLET in 1 BOTTLE (51672-4179-4) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
| Approval Date: | Jul 22, 2019 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
| Approval Date: | Jul 22, 2019 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 4MG | ||||
| Approval Date: | Jul 22, 2019 | TE: | RLD: | No | |||||
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