Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 209463
Company: HIKMA
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 40MG BASE/VIAL | POWDER;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 |
---|---|---|---|---|---|---|---|
06/30/2017 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209463s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209463Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209463Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/18/2023 | SUPPL-21 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209463s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209463Orig1s021ltr.pdf | |
03/04/2022 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209463s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209463Orig1s015ltr.pdf | |
07/26/2021 | SUPPL-13 | Manufacturing (CMC)-Manufacturing Process |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209463Orig1s013ltr.pdf |
11/27/2020 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209463s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209463Orig1s011ltr.pdf | |
06/23/2020 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209463s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209463Orig1s006ltr.pdf | |
10/10/2018 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209463s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209463Orig1s005Ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209463Orig1s005Ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
07/18/2023 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209463s021lbl.pdf | |
03/04/2022 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209463s015lbl.pdf | |
11/27/2020 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209463s011lbl.pdf | |
06/23/2020 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209463s006lbl.pdf | |
10/10/2018 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209463s005lbl.pdf | |
06/30/2017 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209463s000lbl.pdf |