Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022283
Company: RILEY CONSUMER
Company: RILEY CONSUMER
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ZEGERID OTC | OMEPRAZOLE; SODIUM BICARBONATE | 20MG/PACKET;1.68GM/PACKET | FOR SUSPENSION;ORAL | Over-the-counter | None | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
06/17/2013 | ORIG-1 | Approval | Type 8 - Partial Rx to OTC Switch | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022283Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022283Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022283Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022283Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/23/2022 | SUPPL-4 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022283Orig1s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022283Orig1s004ltr.pdf | |
01/15/2019 | SUPPL-3 | Labeling-Container/Carton Labels, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022283Orig1s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022283Orig1s003ltr.pdf | |
10/30/2017 | SUPPL-2 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022283Orig1s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022283Orig1s002ltr.pdf | |
06/11/2015 | SUPPL-1 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022283Orig1s001bll.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022283Orig1s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
11/23/2022 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022283Orig1s004lbl.pdf | |
01/15/2019 | SUPPL-3 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022283Orig1s003lbl.pdf | |
01/15/2019 | SUPPL-3 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022283Orig1s003lbl.pdf | |
10/30/2017 | SUPPL-2 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022283Orig1s002lbl.pdf | |
06/11/2015 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022283Orig1s001bll.pdf | |
06/17/2013 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022283Orig1s000lbl.pdf |
ZEGERID OTC
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
FOR SUSPENSION;ORAL; 20MG/PACKET;1.68GM/PACKET
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
ZEGERID OTC | OMEPRAZOLE; SODIUM BICARBONATE | 20MG/PACKET;1.68GM/PACKET | FOR SUSPENSION;ORAL | Over-the-counter | Yes | 022283 | RILEY CONSUMER |