Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021229
Company: ASTRAZENECA
Company: ASTRAZENECA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PRILOSEC OTC | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | 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 |
|---|---|---|---|---|---|---|---|
| 06/20/2003 | ORIG-1 | Approval | Type 2 - New Active Ingredient and Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21229lbl_Part2.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21229ltr_Prilosec.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-229_Prilosec.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/04/2022 | SUPPL-35 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021229Orig1s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021229Orig1s035ltr.pdf | |
| 01/30/2020 | SUPPL-34 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021229s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021229Orig1s034ltr.pdf | |
| 04/04/2019 | SUPPL-33 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021229Orig1s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021229Orig1s033ltr.pdf | |
| 06/12/2018 | SUPPL-32 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021229Orig1s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021229Orig1s032ltr.pdf | |
| 04/03/2018 | SUPPL-31 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021229Orig1s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021229Orig1s031ltr.pdf | |
| 10/12/2016 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021229Orig1s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021229Orig1s029ltr.pdf | |
| 05/15/2014 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/22/2015 | SUPPL-26 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021229Orig1s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021229Orig1s026ltr.pdf | |
| 09/06/2013 | SUPPL-25 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021229Orig1s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021229Orig1s025ltr.pdf | |
| 09/13/2012 | SUPPL-24 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021229Orig1s024ltr.pdf |
| 08/29/2011 | SUPPL-23 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021229Orig1s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021229s023ltr.pdf | |
| 06/16/2011 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/22/2011 | SUPPL-21 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021229s021ltr.pdf |
| 06/20/2011 | SUPPL-20 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021229s020ltr.pdf |
| 02/25/2011 | SUPPL-19 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021229s019ltr.pdf |
| 12/20/2010 | SUPPL-17 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021229s017ltr.pdf |
| 07/06/2010 | SUPPL-14 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021229s014ltr.pdf |
| 09/09/2009 | SUPPL-13 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021229s013ltr.pdf |
| 06/18/2008 | SUPPL-10 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021229s010ltr.pdf |
| 02/29/2008 | SUPPL-9 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021229s009ltr.pdf |
| 01/18/2008 | SUPPL-8 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021229s008ltr.pdf |
| 03/19/2007 | SUPPL-6 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021229s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021229s006ltr.pdf | |
| 10/02/2006 | SUPPL-5 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021229s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021229s005LTR.pdf | |
| 12/20/2004 | SUPPL-2 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21229s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21229s002ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/04/2022 | SUPPL-35 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021229Orig1s035lbl.pdf | |
| 01/30/2020 | SUPPL-34 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021229s034lbl.pdf | |
| 04/04/2019 | SUPPL-33 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021229Orig1s033lbl.pdf | |
| 06/12/2018 | SUPPL-32 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021229Orig1s032lbl.pdf | |
| 04/03/2018 | SUPPL-31 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021229Orig1s031lbl.pdf | |
| 10/12/2016 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021229Orig1s029lbl.pdf | |
| 06/22/2015 | SUPPL-26 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021229Orig1s026lbl.pdf | |
| 09/06/2013 | SUPPL-25 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021229Orig1s025lbl.pdf | |
| 08/29/2011 | SUPPL-23 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021229Orig1s023lbl.pdf | |
| 03/19/2007 | SUPPL-6 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021229s006lbl.pdf | |
| 10/02/2006 | SUPPL-5 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021229s005lbl.pdf | |
| 12/20/2004 | SUPPL-2 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21229s002lbl.pdf | |
| 06/20/2003 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21229lbl_Part2.pdf |
PRILOSEC OTC
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; EQ 20MG BASE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| OMEPRAZOLE MAGNESIUM | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE;ORAL | Over-the-counter | No | 206877 | AUROBINDO PHARMA |
| OMEPRAZOLE MAGNESIUM | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE;ORAL | Over-the-counter | No | 211732 | HETERO LABS LTD III |
| OMEPRAZOLE MAGNESIUM | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE;ORAL | Over-the-counter | No | 206582 | P AND L |
| PRILOSEC OTC | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE;ORAL | Over-the-counter | Yes | 021229 | ASTRAZENECA |