Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076515
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OMEPRAZOLE OMEPRAZOLE 40MG 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
01/21/2009 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-29 Labeling-Package Insert

Label is not available on this site.

09/28/2017 SUPPL-27 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

03/30/2016 SUPPL-24 Labeling-Package Insert

Label is not available on this site.

03/30/2016 SUPPL-21 Labeling-Package Insert

Label is not available on this site.

03/30/2016 SUPPL-20 Labeling-Package Insert

Label is not available on this site.

12/19/2013 SUPPL-18 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/19/2013 SUPPL-16 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/20/2012 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

02/14/2012 SUPPL-12 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

02/14/2012 SUPPL-11 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

02/14/2012 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

01/04/2011 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

11/23/2010 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

09/07/2010 SUPPL-4 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

OMEPRAZOLE

CAPSULE, DELAYED REL PELLETS;ORAL; 40MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OMEPRAZOLE OMEPRAZOLE 40MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 075347 ACTAVIS LABS FL INC
OMEPRAZOLE OMEPRAZOLE 40MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 076048 APOTEX
OMEPRAZOLE OMEPRAZOLE 40MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 203270 AUROBINDO PHARMA LTD
OMEPRAZOLE OMEPRAZOLE 40MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 203481 BRECKENRIDGE
OMEPRAZOLE OMEPRAZOLE 40MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 075576 DR REDDYS LABS LTD
OMEPRAZOLE OMEPRAZOLE 40MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 078490 DR REDDYS LABS LTD
OMEPRAZOLE OMEPRAZOLE 40MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 091672 GLENMARK GENERICS
OMEPRAZOLE OMEPRAZOLE 40MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 075785 IMPAX LABS
OMEPRAZOLE OMEPRAZOLE 40MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 075410 LANNETT CO INC
OMEPRAZOLE OMEPRAZOLE 40MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 202384 LUPIN LTD
OMEPRAZOLE OMEPRAZOLE 40MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 205070 MYLAN
OMEPRAZOLE OMEPRAZOLE 40MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 076515 SANDOZ
OMEPRAZOLE OMEPRAZOLE 40MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 204661 TEVA PHARMS USA
OMEPRAZOLE OMEPRAZOLE 40MG CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 091352 ZYDUS PHARMS USA INC

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