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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075876
Company: STRIDES PHARMA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OMEPRAZOLE OMEPRAZOLE 10MG CAPSULE, DELAYED REL PELLETS;ORAL Discontinued None No No
OMEPRAZOLE OMEPRAZOLE 20MG CAPSULE, DELAYED REL PELLETS;ORAL Discontinued None No No
OMEPRAZOLE OMEPRAZOLE 40MG CAPSULE, DELAYED REL PELLETS;ORAL Discontinued None No 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
05/29/2003 ORIG-1 Approval

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/18/2023 SUPPL-45 Labeling-Package Insert

Label is not available on this site.
03/04/2022 SUPPL-44 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
11/27/2020 SUPPL-42 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
06/07/2018 SUPPL-41 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
05/31/2018 SUPPL-40 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
05/31/2018 SUPPL-39 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
03/20/2015 SUPPL-37 Labeling-Package Insert

Label is not available on this site.
03/20/2015 SUPPL-36 Labeling-Package Insert

Label is not available on this site.
03/20/2015 SUPPL-33 Labeling-Package Insert

Label is not available on this site.
09/03/2014 SUPPL-32 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.
08/09/2012 SUPPL-30 Labeling-Package Insert

Label is not available on this site.
06/14/2012 SUPPL-28 Labeling-Container/Carton Labels

Label is not available on this site.
08/09/2012 SUPPL-27 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.
08/09/2012 SUPPL-26 Labeling-Package Insert

Label is not available on this site.
11/23/2010 SUPPL-25 Labeling-Package Insert

Label is not available on this site.
07/31/2008 SUPPL-18 Labeling

Label is not available on this site.
03/21/2007 SUPPL-15 Labeling

Label is not available on this site.
09/26/2006 SUPPL-14 Labeling

Label is not available on this site.
11/21/2005 SUPPL-9 Labeling

Label is not available on this site.
01/21/2009 SUPPL-8 Labeling

Label is not available on this site.
06/01/2004 SUPPL-7 Labeling

Label is not available on this site.
03/19/2004 SUPPL-6 Labeling

Label is not available on this site.
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