Details for New Drug Application (NDA): 211146
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NDA 211146 describes VORTIOXETINE HYDROBROMIDE, which is a drug marketed by Zydus Pharms and is included in one NDA. Additional details are available on the VORTIOXETINE HYDROBROMIDE profile page.
The generic ingredient in VORTIOXETINE HYDROBROMIDE is vortioxetine hydrobromide. There are sixteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the vortioxetine hydrobromide profile page.
The generic ingredient in VORTIOXETINE HYDROBROMIDE is vortioxetine hydrobromide. There are sixteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the vortioxetine hydrobromide profile page.
Summary for 211146
| Tradename: | VORTIOXETINE HYDROBROMIDE |
| Applicant: | Zydus Pharms |
| Ingredient: | vortioxetine hydrobromide |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE | ||||
| Approval Date: | Sep 17, 2021 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
| Approval Date: | Sep 17, 2021 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 20MG BASE | ||||
| Approval Date: | Sep 17, 2021 | TE: | RLD: | No | |||||
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