Application 210806
- Type
- NDA
- Sponsor
- MSD MERCK CO
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PIFELTRO | DORAVIRINE | TABLET;ORAL | 100MG | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0006-3069 | PIFELTRO | doravirine | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-3069 | PIFELTRO | doravirine | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-3069 | PIFELTRO | doravirine | Merck Sharp & Dohme LLC | NDA | Current |
| 0006-3069 | PIFELTRO | doravirine | Merck Sharp & Dohme LLC | NDA | Current |
| 0006-3069 | PIFELTRO | doravirine | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-3069 | PIFELTRO | doravirine | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-3069 | PIFELTRO | doravirine | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-3069 | PIFELTRO | doravirine | Merck Sharp & Dohme Corp. | NDA | Current |
| 50090-6237 | PIFELTRO | doravirine | A-S Medication Solutions | NDA | Current |
| 50090-6268 | PIFELTRO | doravirine | A-S Medication Solutions | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 84028 | SUPPL | 2025-10-31 |
| 80186 | SUPPL | 2024-11-08 |
| 80182 | SUPPL | 2024-11-08 |
| 70022 | SUPPL | 2022-02-01 |
| 70006 | SUPPL | 2022-01-31 |
| 60540 | SUPPL | 2019-10-11 |
| 60535 | SUPPL | 2019-10-11 |
| 60076 | SUPPL | 2019-09-20 |
| 60072 | SUPPL | 2019-09-20 |
| 55852 | ORIG | 2018-10-09 |
| 55373 | ORIG | 2018-08-30 |
| 55372 | ORIG | 2018-08-30 |