Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050757
Company: TAKEDA PHARMS USA
Company: TAKEDA PHARMS USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PREVPAC (COPACKAGED) | AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE | 500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL | Discontinued | None | Yes | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/07/2018 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050757s022lbl.pdf | |
| 11/29/2017 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050757s021lbl.pdf |
| 03/01/2017 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050757s018lbl.pdf | |
| 03/01/2017 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050757s018lbl.pdf | |
| 10/24/2016 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050757s020lbl.pdf | |
| 12/19/2014 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050757s019lbl.pdf | |
| 11/06/2013 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050757s017lbl.pdf | |
| 10/30/2007 | SUPPL-15 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050757s015lbl.pdf | |
| 04/20/2005 | SUPPL-11 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050757s011lbl.pdf | |
| 11/22/2002 | SUPPL-8 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50757slr006,008_prevpac_lbl.pdf | |
| 11/22/2002 | SUPPL-6 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50757slr006,008_prevpac_lbl.pdf | |
| 10/22/1999 | SUPPL-4 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50-757S004_Prevpac_prntlbl.pdf | |
| 08/20/1999 | SUPPL-3 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50-757S003_Prevpac_prntlbl.pdf | |
| 01/22/1999 | SUPPL-2 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/50757s2lbl.pdf |