Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022032
Company: DEXCEL PHARMA
Company: DEXCEL PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| OMEPRAZOLE | OMEPRAZOLE | 20MG | TABLET, 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 |
|---|---|---|---|---|---|---|---|
| 12/04/2007 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Letter (PDF)
Letter (PDF) Review Summary Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022032s000TAltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022032s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022032_omeprazole_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022032s000_SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/30/2022 | SUPPL-57 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022032Orig1s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022032Orig1s057ltr.pdf | |
| 10/21/2021 | SUPPL-52 | Manufacturing (CMC)-Formulation |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022032Orig1s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022032Orig1s052ltr.pdf | |
| 07/07/2021 | SUPPL-46 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022032Orig1s046ltr.pdf |
| 04/08/2019 | SUPPL-41 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022032Orig1s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022032Orig1s041ltr.pdf | |
| 11/13/2017 | SUPPL-38 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022032Orig1s038lbl.pdF https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022032Orig1s038ltr.pdf | |
| 10/30/2017 | SUPPL-37 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022032Orig1s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022032Orig1s037ltr.pdf | |
| 12/01/2016 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/10/2016 | SUPPL-32 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022032Orig1s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022032Orig1s032ltr.pdf | |
| 02/08/2016 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/11/2015 | SUPPL-29 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022032Orig1s029lbll.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022032Orig1s029ltr.pdf | |
| 06/01/2015 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/30/2015 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/07/2015 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/05/2016 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/06/2015 | SUPPL-24 | Manufacturing (CMC) |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022032Orig1s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022032Orig1s024ltr.pdf | |
| 09/13/2013 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/16/2013 | SUPPL-21 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022032Orig1s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022032Orig1s021ltr.pdf | |
| 10/29/2012 | SUPPL-20 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022032Orig1s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022032Orig1s020ltr.pdf | |
| 09/10/2012 | SUPPL-19 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022032Orig1s019ltr.pdf |
| 04/09/2012 | SUPPL-16 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022032s016ltr.pdf |
| 06/27/2011 | SUPPL-12 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022032s012ltr.pdf |
| 07/16/2010 | SUPPL-8 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022032s008ltr.pdf |
| 09/21/2009 | SUPPL-4 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 04/02/2009 | SUPPL-3 | Labeling |
Label (PDF)
Letter (PDF) Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022032s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022032s003ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022032s003GenAdviceltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/30/2022 | SUPPL-57 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022032Orig1s057lbl.pdf | |
| 10/21/2021 | SUPPL-52 | Manufacturing (CMC)-Formulation | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022032Orig1s052lbl.pdf | |
| 04/08/2019 | SUPPL-41 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022032Orig1s041lbl.pdf | |
| 11/13/2017 | SUPPL-38 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022032Orig1s038lbl.pdF | |
| 10/30/2017 | SUPPL-37 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022032Orig1s037lbl.pdf | |
| 02/10/2016 | SUPPL-32 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022032Orig1s032lbl.pdf | |
| 06/11/2015 | SUPPL-29 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022032Orig1s029lbll.pdf | |
| 03/06/2015 | SUPPL-24 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022032Orig1s024lbl.pdf |
| 08/16/2013 | SUPPL-21 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022032Orig1s021lbl.pdf | |
| 10/29/2012 | SUPPL-20 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022032Orig1s020lbl.pdf | |
| 04/02/2009 | SUPPL-3 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022032s003lbl.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, DELAYED RELEASE;ORAL; 20MG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| OMEPRAZOLE | OMEPRAZOLE | 20MG | TABLET, DELAYED RELEASE;ORAL | Over-the-counter | No | 210070 | APOTEX |
| OMEPRAZOLE | OMEPRAZOLE | 20MG | TABLET, DELAYED RELEASE;ORAL | Over-the-counter | Yes | 022032 | DEXCEL PHARMA |
| OMEPRAZOLE | OMEPRAZOLE | 20MG | TABLET, DELAYED RELEASE;ORAL | Over-the-counter | No | 207740 | DR REDDYS |
| OMEPRAZOLE | OMEPRAZOLE | 20MG | TABLET, DELAYED RELEASE;ORAL | Over-the-counter | No | 207891 | SUN PHARM |