Details for New Drug Application (NDA): 205422
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NDA 205422 describes REXULTI, which is a drug marketed by Otsuka and is included in one NDA. It is available from two suppliers. There are six patents protecting this drug. Additional details are available on the REXULTI profile page.
The generic ingredient in REXULTI is brexpiprazole. There are eight drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the brexpiprazole profile page.
The generic ingredient in REXULTI is brexpiprazole. There are eight drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the brexpiprazole profile page.
Summary for 205422
| Tradename: | REXULTI |
| Applicant: | Otsuka |
| Ingredient: | brexpiprazole |
| Patents: | 6 |
Suppliers and Packaging for NDA: 205422
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| REXULTI | brexpiprazole | TABLET;ORAL | 205422 | NDA | Otsuka America Pharmaceutical, Inc. | 59148-035 | 59148-035-13 | 1 BOTTLE in 1 CARTON (59148-035-13) / 30 TABLET in 1 BOTTLE |
| REXULTI | brexpiprazole | TABLET;ORAL | 205422 | NDA | Otsuka America Pharmaceutical, Inc. | 59148-036 | 59148-036-07 | 1 BLISTER PACK in 1 CARTON (59148-036-07) / 7 TABLET in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.25MG | ||||
| Approval Date: | Jul 10, 2015 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | May 8, 2027 | ||||||||
| Regulatory Exclusivity Use: | ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION | ||||||||
| Regulatory Exclusivity Expiration: | Dec 27, 2024 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
| Regulatory Exclusivity Expiration: | Nov 10, 2026 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
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