Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 209940
Company: MERCK SHARP DOHME
Company: MERCK SHARP DOHME
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PREVYMIS | LETERMOVIR | 240MG/12ML (20MG/ML) | SOLUTION;INTRAVENOUS | Prescription | None | Yes | Yes |
PREVYMIS | LETERMOVIR | 480MG/24ML (20MG/ML) | SOLUTION;INTRAVENOUS | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
11/08/2017 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209939Orig1s000,209940Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209939Orig1s000209940Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209939Orig1s000,209940Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/30/2024 | SUPPL-16 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209939s013s016,209940s012s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/209939Orig1s013, s016; 209940Orig1s012, 016ltr.pdf | |
08/30/2024 | SUPPL-12 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209939s013s016,209940s012s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/209939Orig1s013, s016; 209940Orig1s012, 016ltr.pdf | |
06/05/2023 | SUPPL-11 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209939s012,209940s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209939Orig1s012;209940Orig1s011ltr.pdf | |
08/02/2023 | SUPPL-10 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209939s011,209940s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209939Orig1s011,209940Orig1s010ltr.pdf | |
03/23/2020 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209939s008,209940s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209939Orig1s008, 209940Orig1s006ltr.pdf | |
12/20/2019 | SUPPL-4 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209939s006,209940s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209939Orig1s006; 209940Orig1s004ltr.pdf | |
08/29/2019 | SUPPL-3 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209939s005,209940s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209939Orig1s005, 209940Orig1s003ltr.pdf | |
03/05/2019 | SUPPL-1 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209939s003,209940s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209939Orig1s003,209940Orig1s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
08/30/2024 | SUPPL-16 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209939s013s016,209940s012s016lbl.pdf | |
08/30/2024 | SUPPL-12 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209939s013s016,209940s012s016lbl.pdf | |
08/02/2023 | SUPPL-10 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209939s011,209940s010lbl.pdf | |
06/05/2023 | SUPPL-11 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209939s012,209940s011lbl.pdf | |
03/23/2020 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209939s008,209940s006lbl.pdf | |
12/20/2019 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209939s006,209940s004lbl.pdf | |
08/29/2019 | SUPPL-3 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209939s005,209940s003lbl.pdf | |
08/29/2019 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209939s005,209940s003lbl.pdf | |
03/05/2019 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209939s003,209940s001lbl.pdf | |
11/08/2017 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209939Orig1s000,209940Orig1s000lbl.pdf |