Details for New Drug Application (NDA): 204370
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NDA 204370 describes VRAYLAR, which is a drug marketed by Allergan and is included in one NDA. It is available from two suppliers. There are four 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. Two suppliers are 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. Two suppliers are listed for this compound. Additional details are available on the cariprazine hydrochloride profile page.
Summary for 204370
| Tradename: | VRAYLAR |
| Applicant: | Allergan |
| Ingredient: | cariprazine hydrochloride |
| Patents: | 4 |
| Formulation / Manufacturing: | see details |
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: | May 24, 2022 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR I DISORDER (BIPOLAR DEPRESSION) | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Sep 17, 2029 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | TREATMENT OF ACUTE MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER WITH CARIPRAZINE | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Sep 17, 2029 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | TREATMENT OF DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR I DISORDER (BIPOLAR DEPRESSION) WITH CARIPRAZINE | ||||||||
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