Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022056
Company: COVIS PHARMA BV
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PRILOSEC OMEPRAZOLE MAGNESIUM EQ 2.5MG BASE/PACKET FOR SUSPENSION, DELAYED RELEASE;ORAL Prescription None Yes No
PRILOSEC OMEPRAZOLE MAGNESIUM EQ 10MG BASE/PACKET FOR SUSPENSION, DELAYED RELEASE;ORAL Prescription 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
03/20/2008 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022056s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022056_prilosec_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022056s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/24/2016 SUPPL-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019810s103,022056s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019810Orig1s103,022056Orig1s020ltr.pdf
12/19/2016 SUPPL-19 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019810s102,022056s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019810Orig1s102,022056Orig1s019ltr.pdf
02/03/2016 SUPPL-18 Efficacy-Pediatric Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022056s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022056Orig1s018ltr.pdf
12/19/2014 SUPPL-17 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022056s017lbl019810s101lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019810Orig1s101,022056Orig1s017ltr.pdf
02/25/2014 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019810s099,022056s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019810Orig1s099,022056Orig1s015ltr.pdf
03/27/2014 SUPPL-14 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019810s098,022056s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019810Orig1s098,022056Orig1s014ltr.pdf
05/15/2013 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019810s097,022056s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019810Orig1s097,022056Orig1s013ltr.pdf
09/28/2012 SUPPL-12 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019810s096lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019810Orig1s096,022056Orig1s012ltr.pdf
10/09/2012 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019810s095,022056s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019810Orig1s095,022056Orig1s011ltr.pdf
01/20/2012 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019810s094,022056s010lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019810s094,022056s010ltr.pdf
05/20/2011 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019810s093,022056s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019810s093,022056s009ltr.pdf
01/20/2011 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019810s092,022056s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019810s092,022056s008ltr.pdf
06/30/2011 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022056s007,019810s091lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022056s007,019810s091ltr.pdf
09/03/2010 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019810s090,022056s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019810s090,022056s005ltr.pdf
03/03/2010 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019810s088,022056s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019810s088,022056s003ltr.pdf
12/01/2008 SUPPL-1 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022056s001019810s087lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019810s087, 022056s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/19/2016 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019810s102,022056s019lbl.pdf
10/24/2016 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019810s103,022056s020lbl.pdf
02/03/2016 SUPPL-18 Efficacy-Pediatric Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022056s018lbl.pdf
12/19/2014 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022056s017lbl019810s101lbl.pdf
12/19/2014 SUPPL-17 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022056s017lbl019810s101lbl.pdf
03/27/2014 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019810s098,022056s014lbl.pdf
02/25/2014 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019810s099,022056s015lbl.pdf
05/15/2013 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019810s097,022056s013lbl.pdf
10/09/2012 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019810s095,022056s011lbl.pdf
09/28/2012 SUPPL-12 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019810s096lbl.pdf
01/20/2012 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019810s094,022056s010lbledt.pdf
06/30/2011 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022056s007,019810s091lbl.pdf
05/20/2011 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019810s093,022056s009lbl.pdf
01/20/2011 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019810s092,022056s008lbl.pdf
09/03/2010 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019810s090,022056s005lbl.pdf
03/03/2010 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019810s088,022056s003lbl.pdf
12/01/2008 SUPPL-1 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022056s001019810s087lbl.pdf
03/20/2008 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022056lbl.pdf

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