An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 213725
Company: SUN PHARM

Products on ANDA 213725

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 213725

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/30/2020	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/213725Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/29/2023	SUPPL-6	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/27/2022	SUPPL-4	Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide		Label is not available on this site.
06/04/2021	SUPPL-1	Labeling-Medication Guide, Labeling-Patient Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 213725

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

Top