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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213699
Company: AJANTA PHARMA LTD

Products on ANDA 213699

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM; NAPROXEN	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE;ORAL	Prescription	AB	No	No
NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM; NAPROXEN	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213699

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/06/2022	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
11/22/2024	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
10/04/2024	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 213699

NAPROXEN AND ESOMEPRAZOLE MAGNESIUM

TABLET, DELAYED RELEASE;ORAL; EQ 20MG BASE;375MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM; NAPROXEN	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	213699	AJANTA PHARMA LTD
NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM; NAPROXEN	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	204206	DR REDDYS
NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM; NAPROXEN	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	217738	SCIEGEN PHARMS

TABLET, DELAYED RELEASE;ORAL; EQ 20MG BASE;500MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM; NAPROXEN	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	213699	AJANTA PHARMA LTD
NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM; NAPROXEN	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	204206	DR REDDYS
NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM; NAPROXEN	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	217738	SCIEGEN PHARMS

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