Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078878
Company: DR REDDYS LABS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OMEPRAZOLE MAGNESIUM OMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE;ORAL Over-the-counter None No 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
06/05/2009 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/078878Orig1s000.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/08/2016 SUPPL-22 Labeling-Container/Carton Labels

Label is not available on this site.

02/14/2014 SUPPL-15 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

10/31/2013 SUPPL-12 Labeling-Container/Carton Labels

Label is not available on this site.

08/27/2012 SUPPL-11 Labeling-Container/Carton Labels

Label is not available on this site.

04/06/2015 SUPPL-10 Labeling-Container/Carton Labels

Label is not available on this site.

11/23/2010 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

OMEPRAZOLE MAGNESIUM

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

CAPSULE, DELAYED RELEASE;ORAL; EQ 20MG BASE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
OMEPRAZOLE MAGNESIUM OMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE;ORAL Over-the-counter No 078878 DR REDDYS LABS LTD
OMEPRAZOLE MAGNESIUM OMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE;ORAL Over-the-counter No 210593 SPIL

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