Application 209940
- Type
- NDA
- Sponsor
- MERCK SHARP DOHME
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PREVYMIS | LETERMOVIR | SOLUTION;INTRAVENOUS | 240MG/12ML (20MG/ML) | Yes | Yes |
| 002 | PREVYMIS | LETERMOVIR | SOLUTION;INTRAVENOUS | 480MG/24ML (20MG/ML) | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0006-5003 | PREVYMIS | LETERMOVIR | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-5003 | PREVYMIS | LETERMOVIR | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-5003 | PREVYMIS | LETERMOVIR | Merck Sharp & Dohme LLC | NDA | Current |
| 0006-5003 | PREVYMIS | LETERMOVIR | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-5003 | PREVYMIS | LETERMOVIR | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-5003 | PREVYMIS | LETERMOVIR | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-5003 | PREVYMIS | LETERMOVIR | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-5003 | PREVYMIS | LETERMOVIR | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-5004 | PREVYMIS | LETERMOVIR | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-5004 | PREVYMIS | LETERMOVIR | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-5004 | PREVYMIS | LETERMOVIR | Merck Sharp & Dohme LLC | NDA | Current |
| 0006-5004 | PREVYMIS | LETERMOVIR | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-5004 | PREVYMIS | LETERMOVIR | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-5004 | PREVYMIS | LETERMOVIR | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-5004 | PREVYMIS | LETERMOVIR | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-5004 | PREVYMIS | LETERMOVIR | Merck Sharp & Dohme Corp. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 81087 | SUPPL | 2025-02-06 |
| 80990 | SUPPL | 2025-02-05 |
| 79521 | SUPPL | 2024-10-15 |
| 79520 | SUPPL | 2024-10-15 |
| 79535 | SUPPL | 2024-09-03 |
| 79534 | SUPPL | 2024-09-03 |
| 74991 | SUPPL | 2023-08-04 |
| 74978 | SUPPL | 2023-08-03 |
| 74453 | SUPPL | 2023-06-06 |
| 74436 | SUPPL | 2023-06-06 |
| 62303 | SUPPL | 2020-03-24 |
| 62280 | SUPPL | 2020-03-24 |
| 61447 | SUPPL | 2019-12-26 |
| 61418 | SUPPL | 2019-12-23 |
| 59896 | SUPPL | 2019-09-03 |
| 59884 | SUPPL | 2019-08-30 |
| 57925 | SUPPL | 2019-03-07 |
| 57920 | SUPPL | 2019-03-07 |
| 50756 | ORIG | 2017-12-18 |
| 50347 | ORIG | 2017-11-08 |
| 50346 | ORIG | 2017-11-08 |