Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076515
Company: SANDOZ

Products on ANDA 076515

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076515

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
10/11/2023	SUPPL-37	Labeling-Package Insert		Label is not available on this site.
03/04/2022	SUPPL-35	Labeling-Package Insert		Label is not available on this site.
11/27/2020	SUPPL-33	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/27/2020	SUPPL-32	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
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.

Therapeutic Equivalents for ANDA 076515

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
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 PHARMS LTD
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	076515	SANDOZ
OMEPRAZOLE	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	No	AB	091352	ZYDUS PHARMS USA INC