FdaApplication
NDA 022044
Identifiers
- fda_app_no: NDA022044
Properties
| Property | Value |
|---|---|
| applicant_name | MERCK SHARP AND DOHME LLC A SUB OF MERCK AND CO INC |
| application_type | NDA |
| approval_date | 2007-03-30 |
Revenue by product
JANUMET
| Period | Revenue |
|---|---|
| Q2 2026 | $171.0M* |
| Q1 2026 | $207.0M* |
| Q4 2025 | $199.0M* |
| Q3 2025 | $243.0M* |
| Q2 2025 | $251.0M* |
| Q1 2025 | $247.0M* |
| Q4 2024 | $256.0M* |
| Q3 2024 | $204.0M* |
| Q2 2024 | $224.0M* |
| Q1 2024 | $251.0M* |
| Q4 2023 | $240.0M* |
| Q3 2023 | $255.0M* |
| Q2 2023 | $354.0M* |
| Q1 2023 | $329.0M* |
| Q4 2022 | $353.0M* |
| Q3 2022 | $417.0M* |
| Q2 2022 | $476.0M* |
| Q1 2022 | $454.0M* |
| Q4 2021 | $515.0M* |
| Q3 2021 | $487.0M* |
| Q2 2021 | $477.0M* |
| Q1 2021 | $486.0M* |
| Q4 2020 | $472.0M* |
| Q3 2020 | $506.0M* |
| Q2 2020 | $490.0M* |
| Q1 2020 | $503.0M* |
| Q4 2019 | $474.0M* |
| Q3 2019 | $503.0M* |
| Q2 2019 | $533.0M* |
| Q1 2019 | $530.0M* |
| Q4 2018 | $535.0M* |
| Q3 2018 | $563.0M* |
| Q2 2018 | $585.0M* |
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 (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| JANUMET | METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE | 1GM;EQ 50MG BASE | TABLET;ORAL |
| JANUMET | METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE | 500MG;EQ 50MG BASE | TABLET;ORAL |
2 products