Details for New Drug Application (NDA): 213982
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NDA 213982 describes CARIPRAZINE HYDROCHLORIDE, which is a drug marketed by Aurobindo Pharma Ltd, Sun Pharm, and Zydus, and is included in three NDAs. Additional details are available on the CARIPRAZINE HYDROCHLORIDE profile page.
The generic ingredient in CARIPRAZINE HYDROCHLORIDE 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 CARIPRAZINE HYDROCHLORIDE 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 213982
| Tradename: | CARIPRAZINE HYDROCHLORIDE |
| Applicant: | Aurobindo Pharma Ltd |
| Ingredient: | cariprazine hydrochloride |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | EQ 1.5MG BASE | ||||
| Approval Date: | Dec 16, 2025 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | EQ 3MG BASE | ||||
| Approval Date: | Dec 16, 2025 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | EQ 6MG BASE | ||||
| Approval Date: | Dec 16, 2025 | TE: | RLD: | No | |||||
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