Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217416
Company: AJANTA PHARMA LTD

Products on ANDA 217416

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 217416

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/09/2023	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
04/23/2024	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 217416

PANTOPRAZOLE SODIUM

FOR SUSPENSION, DELAYED RELEASE;ORAL; EQ 40MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE;ORAL	Prescription	No	AB	217416	AJANTA PHARMA LTD
PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE;ORAL	Prescription	No	AB	216139	ANNORA PHARMA
PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE;ORAL	Prescription	No	AB	216247	DEXCEL
PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE;ORAL	Prescription	No	AB	213725	SUN PHARM
PROTONIX	PANTOPRAZOLE SODIUM	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE;ORAL	Prescription	Yes	AB	022020	WYETH PHARMS