Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021706
Company: SANTARUS
Company: SANTARUS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ZEGERID | OMEPRAZOLE; SODIUM BICARBONATE | 40MG/PACKET;1.68GM/PACKET | FOR SUSPENSION; ORAL | Discontinued | None | Yes | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/21/2004 | ORIG-1 | Approval | Type 6 - New Indication (no longer used) | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021706lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021706ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021706s000_ZegeridTOC.cfm |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/21/2004 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021706lbl.pdf |