Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021636
Company: SANTARUS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZEGERID OMEPRAZOLE; SODIUM BICARBONATE 20MG/PACKET;1.68GM/PACKET FOR SUSPENSION;ORAL Prescription AB Yes No
ZEGERID OMEPRAZOLE; SODIUM BICARBONATE 40MG/PACKET;1.68GM/PACKET FOR SUSPENSION;ORAL Prescription AB 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
06/15/2004 ORIG-1 Approval Type 3 - New Dosage Form and Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21636_zegerid_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21636ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021636s000_ZegeridTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/07/2018 SUPPL-19 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021849s014,021636s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021849Orig1s014,021636Orig1s019ltr.pdf
10/24/2016 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021636s017,021849s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021849Orig1s012,021636Orig1s017ltr.pdf
12/19/2014 SUPPL-16 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021849s010021636s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021636Orig1s016,021849Orig1s010ltr.pdf
02/25/2014 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021636s015,021849s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021636Orig1s015,021849Orig1s009ltr.pdf
12/20/2013 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

04/19/2012 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021636s013,021849s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021636s013,021849s008ltr.pdf
11/09/2012 SUPPL-12 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021636s012,021849s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021636Orig1s012,021849Orig1s007ltr.pdf
12/07/2011 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021636s011,021849s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021636s011,021849s006ltr.pdf
05/20/2011 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021636s010,021849s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021636s010,021849s005ltr.pdf
09/03/2010 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021636s009,021849s004,021850s003,022456s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021636s009,021849s004,021850s003,022456s002ltr.pdf
01/20/2010 SUPPL-8 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021636s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021636s008,021849s003,021850s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/07/2018 SUPPL-19 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021849s014,021636s019lbl.pdf
06/07/2018 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021849s014,021636s019lbl.pdf
10/24/2016 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021636s017,021849s012lbl.pdf
12/19/2014 SUPPL-16 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021849s010021636s016lbl.pdf
12/19/2014 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021849s010021636s016lbl.pdf
02/25/2014 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021636s015,021849s009lbl.pdf
11/09/2012 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021636s012,021849s007lbl.pdf
04/19/2012 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021636s013,021849s008lbl.pdf
12/07/2011 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021636s011,021849s006lbl.pdf
05/20/2011 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021636s010,021849s005lbl.pdf
09/03/2010 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021636s009,021849s004,021850s003,022456s002lbl.pdf
01/20/2010 SUPPL-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021636s008lbl.pdf
06/15/2004 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21636_zegerid_lbl.pdf

ZEGERID

FOR SUSPENSION;ORAL; 20MG/PACKET;1.68GM/PACKET
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OMEPRAZOLE AND SODIUM BICARBONATE OMEPRAZOLE; SODIUM BICARBONATE 20MG/PACKET;1.68GM/PACKET FOR SUSPENSION;ORAL Prescription No AB 205545 AJANTA PHARMA LTD
OMEPRAZOLE AND SODIUM BICARBONATE OMEPRAZOLE; SODIUM BICARBONATE 20MG/PACKET;1.68GM/PACKET FOR SUSPENSION;ORAL Prescription No AB 079182 PAR PHARM
ZEGERID OMEPRAZOLE; SODIUM BICARBONATE 20MG/PACKET;1.68GM/PACKET FOR SUSPENSION;ORAL Prescription Yes AB 021636 SANTARUS INC

FOR SUSPENSION;ORAL; 40MG/PACKET;1.68GM/PACKET
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OMEPRAZOLE AND SODIUM BICARBONATE OMEPRAZOLE; SODIUM BICARBONATE 40MG/PACKET;1.68GM/PACKET FOR SUSPENSION;ORAL Prescription No AB 205545 AJANTA PHARMA LTD
OMEPRAZOLE AND SODIUM BICARBONATE OMEPRAZOLE; SODIUM BICARBONATE 40MG/PACKET;1.68GM/PACKET FOR SUSPENSION;ORAL Prescription No AB 079182 PAR PHARM
ZEGERID OMEPRAZOLE; SODIUM BICARBONATE 40MG/PACKET;1.68GM/PACKET FOR SUSPENSION;ORAL Prescription Yes AB 021636 SANTARUS INC

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