Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 210491
Company: VERTEX PHARMS INC
Company: VERTEX PHARMS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SYMDEKO (COPACKAGED) | IVACAFTOR; IVACAFTOR, TEZACAFTOR | 150MG;150MG, 100MG | TABLET;ORAL | Prescription | None | Yes | Yes |
SYMDEKO (COPACKAGED) | IVACAFTOR; IVACAFTOR, TEZACAFTOR | 75MG;75MG, 50MG | TABLET;ORAL | Prescription | None | Yes | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
02/12/2018 | ORIG-1 | Approval | Type 1 - New Molecular Entity and Type 4 - New Combination | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210491lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210491Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210491Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/03/2023 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210491s011lbl.pdf | |
12/21/2020 | SUPPL-7 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210491s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/210491Orig1s007ltr.pdf | |
12/27/2019 | SUPPL-5 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210491s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210491Orig1s005ltr.pdf | |
06/21/2019 | SUPPL-3 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210491s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210491Orig1s003ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
08/03/2023 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210491s011lbl.pdf | |
12/21/2020 | SUPPL-7 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210491s007lbl.pdf | |
12/27/2019 | SUPPL-5 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210491s005lbl.pdf | |
12/27/2019 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210491s005lbl.pdf | |
06/21/2019 | SUPPL-3 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210491s003lbl.pdf | |
02/12/2018 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210491lbl.pdf |