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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209716
Company: AMNEAL PHARMS NY

Products on ANDA 209716

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209716

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/05/2019	ORIG-1	Approval		STANDARD		Label is not available on this site.

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

ESOMEPRAZOLE 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
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE;ORAL	Over-the-counter	No	209716	AMNEAL PHARMS NY
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE;ORAL	Over-the-counter	No	209339	AUROBINDO PHARMA
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE;ORAL	Over-the-counter	No	207673	DR REDDYS
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE;ORAL	Over-the-counter	No	216349	GRAVITI PHARMS
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE;ORAL	Over-the-counter	No	216149	GUARDIAN DRUG
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE;ORAL	Over-the-counter	No	212507	HETERO LABS LTD III
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE;ORAL	Over-the-counter	No	207193	PERRIGO R AND D
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE;ORAL	Over-the-counter	No	212866	SUN PHARM
NEXIUM 24HR	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE;ORAL	Over-the-counter	Yes	204655	ASTRAZENECA LP

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