Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 216139
Company: ANNORA PHARMA

Products on ANDA 216139

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 216139

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/27/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 216139

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	217923	AUROBINDO PHARMA LTD
PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE;ORAL	Prescription	No	AB	217458	CIPLA
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