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Abbreviated New Drug Application (ANDA): 213725
Company: SUN PHARM
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
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
09/27/2022 SUPPL-4 Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert

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.

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 213725 SUN PHARM
PROTONIX PANTOPRAZOLE SODIUM EQ 40MG BASE FOR SUSPENSION, DELAYED RELEASE;ORAL Prescription Yes AB 022020 WYETH PHARMS
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