Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075757
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OMEPRAZOLE OMEPRAZOLE 10MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription AB No No
OMEPRAZOLE OMEPRAZOLE 20MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription AB 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
01/28/2003 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-49 Labeling-Package Insert

Label is not available on this site.

09/28/2017 SUPPL-46 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

04/14/2015 SUPPL-43 Labeling-Package Insert

Label is not available on this site.

04/14/2015 SUPPL-42 Labeling-Package Insert

Label is not available on this site.

04/14/2015 SUPPL-39 Labeling-Package Insert

Label is not available on this site.

04/14/2015 SUPPL-38 Labeling-Package Insert

Label is not available on this site.

12/31/2013 SUPPL-36 Labeling-Package Insert

Label is not available on this site.

12/31/2013 SUPPL-33 Labeling-Package Insert

Label is not available on this site.

10/31/2014 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

09/19/2012 SUPPL-31 Labeling-Package Insert

Label is not available on this site.

02/13/2012 SUPPL-29 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

02/13/2012 SUPPL-28 Labeling-Package Insert

Label is not available on this site.

02/13/2012 SUPPL-27 Labeling-Package Insert

Label is not available on this site.

01/07/2011 SUPPL-25 Labeling-Package Insert

Label is not available on this site.

02/26/2010 SUPPL-20 Labeling

Label is not available on this site.

11/16/2007 SUPPL-16 Labeling

Label is not available on this site.

08/24/2006 SUPPL-13 Labeling

Label is not available on this site.

03/21/2007 SUPPL-11 Labeling

Label is not available on this site.

07/12/2005 SUPPL-8 Labeling

Label is not available on this site.

09/29/2005 SUPPL-7 Labeling

Label is not available on this site.

05/19/2004 SUPPL-4 Labeling

Label is not available on this site.

OMEPRAZOLE

CAPSULE, DELAYED REL PELLETS;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OMEPRAZOLE OMEPRAZOLE 10MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 075347 ACTAVIS LABS FL INC
OMEPRAZOLE OMEPRAZOLE 10MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 076048 APOTEX
OMEPRAZOLE OMEPRAZOLE 10MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 203270 AUROBINDO PHARMA LTD
OMEPRAZOLE OMEPRAZOLE 10MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 203481 BRECKENRIDGE
OMEPRAZOLE OMEPRAZOLE 10MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 075576 DR REDDYS LABS LTD
OMEPRAZOLE OMEPRAZOLE 10MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 078490 DR REDDYS LABS LTD
OMEPRAZOLE OMEPRAZOLE 10MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 091672 GLENMARK GENERICS
OMEPRAZOLE OMEPRAZOLE 10MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 204012 HETERO LABS LTD III
OMEPRAZOLE OMEPRAZOLE 10MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 075785 IMPAX LABS
OMEPRAZOLE OMEPRAZOLE 10MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 075410 LANNETT CO INC
OMEPRAZOLE OMEPRAZOLE 10MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 205070 MYLAN
OMEPRAZOLE OMEPRAZOLE 10MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 075757 SANDOZ
OMEPRAZOLE OMEPRAZOLE 10MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 091352 ZYDUS PHARMS USA INC

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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