Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 209400
Company: DEXCEL
Company: DEXCEL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OMEPRAZOLE | OMEPRAZOLE | 20MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | Over-the-counter | 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 |
---|---|---|---|---|---|---|---|
07/05/2017 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209400Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209400Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209400Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/21/2022 | SUPPL-12 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209400Orig1s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209400Orig1s012ltr.pdf | |
11/13/2020 | SUPPL-10 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209400Orig1s010ltr.pdf |
04/29/2020 | SUPPL-7 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209400Orig1s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209400Orig1s007ltr.pdf | |
07/07/2021 | SUPPL-6 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209400Orig1s006ltr.pdf |
01/28/2019 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209400Orig1s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209400Orig1s005ltr.pdf | |
07/12/2018 | SUPPL-3 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209400Orig1s003Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209400Orig1s003Ltr.pdf | |
06/12/2018 | SUPPL-2 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209400Orig1s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209400Orig1s002ltr.pdf | |
02/28/2018 | SUPPL-1 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209400Orig1s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209400Orig1s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
10/21/2022 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209400Orig1s012lbl.pdf | |
04/29/2020 | SUPPL-7 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209400Orig1s007lbl.pdf | |
01/28/2019 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209400Orig1s005lbl.pdf | |
07/12/2018 | SUPPL-3 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209400Orig1s003Lbl.pdf | |
06/12/2018 | SUPPL-2 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209400Orig1s002lbl.pdf | |
02/28/2018 | SUPPL-1 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209400Orig1s001lbl.pdf | |
07/05/2017 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209400Orig1s000lbl.pdf |
OMEPRAZOLE
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL; 20MG
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
OMEPRAZOLE | OMEPRAZOLE | 20MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | Over-the-counter | Yes | 209400 | DEXCEL |