Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020973
Company: WOODWARD
Company: WOODWARD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACIPHEX | RABEPRAZOLE SODIUM | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE;ORAL | Discontinued | None | Yes | No |
| ACIPHEX | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE;ORAL | Prescription | AB | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/18/2023 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020973s043lbl.pdf | |
| 03/04/2022 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020973s042lbl.pdf | |
| 11/27/2020 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020973s041lbl.pdf | |
| 06/07/2018 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020973s039lbl.pdf | |
| 01/09/2018 | SUPPL-38 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020973s038lbl.pdf | |
| 10/24/2016 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020973s037lbl.pdf | |
| 04/04/2016 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020973s033lbledt.pdf | |
| 12/19/2014 | SUPPL-35 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020973s035204736s005lbl.pdf | |
| 12/19/2014 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020973s035204736s005lbl.pdf | |
| 10/15/2014 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020973s034,204736s004lbl.pdf | |
| 04/19/2013 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020973s032lbl.pdf | |
| 10/05/2012 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020973s029lbl.pdf | |
| 05/08/2012 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020973s030lbl.pdf | |
| 05/20/2011 | SUPPL-28 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020973s028lbl.pdf | |
| 09/03/2010 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020973s025lbl.pdf | |
| 06/30/2008 | SUPPL-22 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020973s022lbl.pdf | |
| 06/03/2005 | SUPPL-20 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020973s020lbl.pdf | |
| 11/08/2002 | SUPPL-13 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20973S013lbl.pdf | |
| 02/12/2002 | SUPPL-9 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20973s009lbl.pdf | |
| 08/15/2001 | SUPPL-8 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20973s8lbl.pdf | |
| 08/19/1999 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20973lbl.pdf |