Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207891
Company: SUN PHARM

Products on ANDA 207891

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 207891

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/12/2018	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207891Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/12/2023	SUPPL-7	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
11/16/2020	SUPPL-2	Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

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

OMEPRAZOLE

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

TABLET, DELAYED RELEASE;ORAL; 20MG

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
OMEPRAZOLE	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE;ORAL	Over-the-counter	No	210070	APOTEX
OMEPRAZOLE	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE;ORAL	Over-the-counter	Yes	022032	DEXCEL PHARMA
OMEPRAZOLE	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE;ORAL	Over-the-counter	No	207740	DR REDDYS
OMEPRAZOLE	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE;ORAL	Over-the-counter	No	207891	SUN PHARM