Details for New Drug Application (NDA): 204370
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NDA 204370 describes VRAYLAR, which is a drug marketed by Abbvie and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the VRAYLAR profile page.
The generic ingredient in VRAYLAR is cariprazine hydrochloride. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cariprazine hydrochloride profile page.
The generic ingredient in VRAYLAR is cariprazine hydrochloride. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cariprazine hydrochloride profile page.
Summary for 204370
| Tradename: | VRAYLAR |
| Applicant: | Abbvie |
| Ingredient: | cariprazine hydrochloride |
| Patents: | 5 |
Suppliers and Packaging for NDA: 204370
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VRAYLAR | cariprazine hydrochloride | CAPSULE;ORAL | 204370 | NDA | Allergan, Inc. | 61874-115 | 61874-115-07 | 7 CAPSULE, GELATIN COATED in 1 BLISTER PACK (61874-115-07) |
| VRAYLAR | cariprazine hydrochloride | CAPSULE;ORAL | 204370 | NDA | Allergan, Inc. | 61874-115 | 61874-115-17 | 1 BLISTER PACK in 1 CARTON (61874-115-17) / 7 CAPSULE, GELATIN COATED in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 1.5MG BASE | ||||
| Approval Date: | Sep 17, 2015 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Dec 18, 2028 | ||||||||
| Regulatory Exclusivity Use: | ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION | ||||||||
| Regulatory Exclusivity Expiration: | Dec 18, 2028 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
| Regulatory Exclusivity Expiration: | Jun 18, 2029 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
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