Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 207921
Company: NORTON WATERFORD
Company: NORTON WATERFORD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
QVAR REDIHALER | BECLOMETHASONE DIPROPIONATE | 0.04MG/INH | AEROSOL, METERED;INHALATION | Prescription | None | Yes | No |
QVAR REDIHALER | BECLOMETHASONE DIPROPIONATE | 0.08MG/INH | AEROSOL, METERED;INHALATION | 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 |
---|---|---|---|---|---|---|---|
08/03/2017 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207921s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207921Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207921Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/06/2021 | SUPPL-4 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/207921Orig1s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/207921Orig1s004ltr.pdf | |
11/19/2018 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/207921Orig1s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/207921Orig1s003ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
01/06/2021 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/207921Orig1s004lbl.pdf | |
01/06/2021 | SUPPL-4 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/207921Orig1s004lbl.pdf | |
11/19/2018 | SUPPL-3 | Tentative Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/207921Orig1s003lbl.pdf | |
08/03/2017 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207921s000lbl.pdf |