Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021566
Company: TAKEDA PHARMS NA
Company: TAKEDA PHARMS NA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PREVACID IV | LANSOPRAZOLE | 30MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INTRAVENOUS | Discontinued | None | Yes | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/31/2009 | SUPPL-5 | Supplement | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021566s005lbl.pdf | |
| 04/05/2005 | SUPPL-1 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021566s001lbl.pdf | |
| 05/27/2004 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21566_prevacid_lb.pdf |