Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075876
Company: MYLAN
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 Prescription AB 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
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-Medication Guide, Labeling-Package Insert

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-Package Insert, Labeling-Container/Carton Labels

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-Package Insert, Labeling-Container/Carton Labels

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.

OMEPRAZOLE

CAPSULE, DELAYED REL PELLETS;ORAL; 20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OMEPRAZOLE OMEPRAZOLE 20MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 075347 ACTAVIS LABS FL INC
OMEPRAZOLE OMEPRAZOLE 20MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 076048 APOTEX
OMEPRAZOLE OMEPRAZOLE 20MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 203270 AUROBINDO PHARMA LTD
OMEPRAZOLE OMEPRAZOLE 20MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 203481 BRECKENRIDGE
OMEPRAZOLE OMEPRAZOLE 20MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 075576 DR REDDYS LABS LTD
OMEPRAZOLE OMEPRAZOLE 20MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 078490 DR REDDYS LABS LTD
OMEPRAZOLE OMEPRAZOLE 20MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 091672 GLENMARK GENERICS
OMEPRAZOLE OMEPRAZOLE 20MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 204012 HETERO LABS LTD III
OMEPRAZOLE OMEPRAZOLE 20MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 075785 IMPAX LABS
OMEPRAZOLE OMEPRAZOLE 20MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 075410 LANNETT CO INC
OMEPRAZOLE OMEPRAZOLE 20MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 075876 MYLAN
OMEPRAZOLE OMEPRAZOLE 20MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 205070 MYLAN
OMEPRAZOLE OMEPRAZOLE 20MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 075757 SANDOZ
OMEPRAZOLE OMEPRAZOLE 20MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 204661 TEVA PHARMS USA
OMEPRAZOLE OMEPRAZOLE 20MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 091352 ZYDUS PHARMS USA INC

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