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 |
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 |