FdaApplication
NDA 019430
Identifiers
- fda_app_no: NDA019430
Properties
| Property | Value |
|---|---|
| applicant_name | VIATRIS SPECIALTY LLC |
| application_type | NDA |
| approval_date | 1987-12-22 |
Revenue by product
EPIPEN
| Period | Revenue |
|---|---|
| Q2 2026 | $129.2M |
| Q1 2026 | $101.1M |
| Q4 2025 | $79.0M |
| Q3 2025 | $157.2M |
| Q2 2025 | $136.8M |
| Q1 2025 | $96.7M |
| Q4 2024 | $73.1M |
| Q3 2024 | $123.2M |
| Q2 2024 | $115.5M |
| Q1 2024 | $80.2M |
| Q4 2023 | $87.0M |
| Q3 2023 | $131.9M |
| Q2 2023 | $127.5M |
| Q1 2023 | $95.8M |
| Q4 2022 | $68.3M |
| Q3 2022 | $114.4M |
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 (4)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| EPI E Z PEN JR | EPINEPHRINE | 0.15MG/DELIVERY | INJECTABLE;INTRAMUSCULAR |
| EPIPEN | EPINEPHRINE | 0.3MG/DELIVERY | INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS |
| EPIPEN E Z PEN | EPINEPHRINE | 0.3MG/DELIVERY | INJECTABLE;INTRAMUSCULAR |
| EPIPEN JR. | EPINEPHRINE | 0.15MG/DELIVERY | INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS |
4 products