FdaApplication
NDA 019839
Identifiers
- fda_app_no: NDA019839
Properties
| Property | Value |
|---|---|
| applicant_name | VIATRIS SPECIALTY LLC |
| application_type | NDA |
| approval_date | 1991-12-30 |
Revenue by product
ZOLOFT
| Period | Revenue |
|---|---|
| Q2 2026 | $71.4M |
| Q1 2026 | $72.6M |
| Q4 2025 | $66.8M |
| Q3 2025 | $66.8M |
| Q2 2025 | $61.1M |
| Q1 2025 | $60.2M |
| Q4 2024 | $58.2M |
| Q3 2024 | $60.6M |
| Q2 2024 | $58.9M |
| Q1 2024 | $58.0M |
| Q4 2023 | $62.0M |
| Q3 2023 | $62.7M |
| Q2 2023 | $54.5M |
| Q1 2023 | $56.5M |
| Q4 2022 | $57.5M |
| Q3 2022 | $53.1M |
Revenue as this company reported it for this product. A combination product's amount is stated once, for the product, and never divided across its ingredients. A fourth quarter is the reported full year less nine months, since no filing states one.
Products (5)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| ZOLOFT | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET;ORAL |
| ZOLOFT | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET;ORAL |
| ZOLOFT | SERTRALINE HYDROCHLORIDE | EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| ZOLOFT | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET;ORAL |
| ZOLOFT | SERTRALINE HYDROCHLORIDE | EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
5 products