Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204661
Company: TEVA PHARMS USA

Products on ANDA 204661

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OMEPRAZOLE	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	AB	No	No
OMEPRAZOLE	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204661

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/13/2017	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
07/18/2023	SUPPL-8	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
03/04/2022	SUPPL-7	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
06/07/2018	SUPPL-2	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.

Therapeutic Equivalents for ANDA 204661

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
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 PHARMS LTD
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	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	212977	XIROMED
OMEPRAZOLE	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	No	AB	091352	ZYDUS PHARMS USA INC