Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022281
Company: BAYER HEALTHCARE LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZEGERID OTC OMEPRAZOLE; SODIUM BICARBONATE 20MG;1.1GM CAPSULE;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
12/01/2009 ORIG-1 Approval Type 8 - Partial Rx to OTC Switch STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022281lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022281s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022281s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/15/2019 SUPPL-13 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022281Orig1s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022281Orig1s013ltr.pdf
10/30/2017 SUPPL-12 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022281Orig1s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022281Orig1s012ltr.pdf
02/17/2017 SUPPL-11 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022281Orig1s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022281Orig1s011ltr.pdf
04/21/2016 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

06/10/2015 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022281s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022281Orig1s008ltr.pdf
11/15/2013 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

09/18/2012 SUPPL-6 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022281Orig1s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022281Orig1s006ltr.pdf
07/25/2011 SUPPL-5 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022281Orig1s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022281s005ltr.pdf
12/20/2010 SUPPL-3 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022281s003ltr.pdf
12/20/2010 SUPPL-2 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022281s002ltr.pdf
04/15/2010 SUPPL-1 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022281s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/15/2019 SUPPL-13 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022281Orig1s013lbl.pdf
10/30/2017 SUPPL-12 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022281Orig1s012lbl.pdf
02/17/2017 SUPPL-11 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022281Orig1s011lbl.pdf
06/10/2015 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022281s008lbl.pdf
09/18/2012 SUPPL-6 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022281Orig1s006lbl.pdf
07/25/2011 SUPPL-5 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022281Orig1s005lbl.pdf
12/01/2009 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022281lbl.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.

CAPSULE;ORAL; 20MG;1.1GM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
OMEPRAZOLE AND SODIUM BICARBONATE OMEPRAZOLE; SODIUM BICARBONATE 20MG;1.1GM CAPSULE;ORAL Over-the-counter No 204137 ACTAVIS ELIZABETH
OMEPRAZOLE AND SODIUM BICARBONATE OMEPRAZOLE; SODIUM BICARBONATE 20MG;1.1GM CAPSULE;ORAL Over-the-counter No 204923 AUROLIFE PHARMA LLC
OMEPRAZOLE AND SODIUM BICARBONATE OMEPRAZOLE; SODIUM BICARBONATE 20MG;1.1GM CAPSULE;ORAL Over-the-counter No 201946 PAR PHARM
OMEPRAZOLE AND SODIUM BICARBONATE OMEPRAZOLE; SODIUM BICARBONATE 20MG;1.1GM CAPSULE;ORAL Over-the-counter No 201361 PERRIGO R AND D
OMEPRAZOLE AND SODIUM BICARBONATE OMEPRAZOLE; SODIUM BICARBONATE 20MG;1.1GM CAPSULE;ORAL Over-the-counter No 203345 ZYDUS PHARMS
ZEGERID OTC OMEPRAZOLE; SODIUM BICARBONATE 20MG;1.1GM CAPSULE;ORAL Over-the-counter Yes 022281 BAYER HEALTHCARE LLC

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