Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078878
Company: DR REDDYS LABS LTD

Products on ANDA 078878

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OMEPRAZOLE MAGNESIUM	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE;ORAL	Over-the-counter	None	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078878

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/05/2009	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/078878Orig1s000.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/02/2023	SUPPL-42	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
06/02/2023	SUPPL-32	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
06/02/2023	SUPPL-30	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
06/02/2023	SUPPL-28	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
06/08/2016	SUPPL-22	Labeling-Container/Carton Labels		Label is not available on this site.
02/14/2014	SUPPL-15	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
10/31/2013	SUPPL-12	Labeling-Container/Carton Labels		Label is not available on this site.
08/27/2012	SUPPL-11	Labeling-Container/Carton Labels		Label is not available on this site.
04/06/2015	SUPPL-10	Labeling-Container/Carton Labels		Label is not available on this site.
11/23/2010	SUPPL-6	Labeling-Package Insert		Label is not available on this site.

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

OMEPRAZOLE MAGNESIUM

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

CAPSULE, DELAYED RELEASE;ORAL; EQ 20MG BASE

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
OMEPRAZOLE MAGNESIUM	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE;ORAL	Over-the-counter	No	216096	DEXCEL
OMEPRAZOLE MAGNESIUM	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE;ORAL	Over-the-counter	No	078878	DR REDDYS LABS LTD