Details for New Drug Application (NDA): 213984
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The generic ingredient in CARIPRAZINE HYDROCHLORIDE 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 213984
Tradename: | CARIPRAZINE HYDROCHLORIDE |
Applicant: | Zydus |
Ingredient: | cariprazine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | EQ 1.5MG BASE | ||||
Approval Date: | Sep 9, 2022 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | EQ 3MG BASE | ||||
Approval Date: | Sep 9, 2022 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | EQ 4.5MG BASE | ||||
Approval Date: | Sep 9, 2022 | TE: | RLD: | No |
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