Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210070
Company: APOTEX

Products on ANDA 210070

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 210070

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/11/2019	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/01/2020	SUPPL-1	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