FdaApplication
NDA 021995
Identifiers
- fda_app_no: NDA021995
Properties
| Property | Value |
|---|---|
| applicant_name | MERCK SHARP AND DOHME LLC |
| application_type | NDA |
| approval_date | 2006-10-16 |
Revenue by product
JANUVIA
| Period | Revenue |
|---|---|
| Q2 2026 | $258.0M |
| Q1 2026 | $367.0M |
| Q4 2025 | $302.0M |
| Q3 2025 | $382.0M |
| Q2 2025 | $372.0M |
| Q1 2025 | $549.0M |
| Q4 2024 | $232.0M |
| Q3 2024 | $278.0M |
| Q2 2024 | $405.0M |
| Q1 2024 | $419.0M |
| Q4 2023 | $547.0M |
| Q3 2023 | $581.0M |
| Q2 2023 | $511.0M |
| Q1 2023 | $551.0M |
| Q4 2022 | $561.0M |
| Q3 2022 | $717.0M |
| Q2 2022 | $756.0M |
| Q1 2022 | $779.0M |
| Q4 2021 | $879.0M |
| Q3 2021 | $852.0M |
| Q2 2021 | $784.0M |
| Q1 2021 | $809.0M |
| Q4 2020 | $857.0M |
| Q3 2020 | $821.0M |
| Q2 2020 | $854.0M |
| Q1 2020 | $774.0M |
| Q4 2019 | $943.0M |
| Q3 2019 | $807.0M |
| Q2 2019 | $908.0M |
| Q1 2019 | $824.0M |
| Q4 2018 | $930.0M |
| Q3 2018 | $927.0M |
| Q2 2018 | $949.0M |
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 (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| JANUVIA | SITAGLIPTIN PHOSPHATE | EQ 50MG BASE | TABLET;ORAL |
| JANUVIA | SITAGLIPTIN PHOSPHATE | EQ 25MG BASE | TABLET;ORAL |
| JANUVIA | SITAGLIPTIN PHOSPHATE | EQ 100MG BASE | TABLET;ORAL |
3 products