U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 218948
Company: AUROBINDO PHARMA LTD

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 5MG BASE/PACKET FOR SUSPENSION, DELAYED RELEASE;ORAL Prescription AB No No
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE/PACKET FOR SUSPENSION, DELAYED RELEASE;ORAL Prescription AB No No
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 40MG BASE/PACKET 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
04/15/2025 ORIG-1 Approval STANDARD

Label is not available on this site.

ESOMEPRAZOLE MAGNESIUM

FOR SUSPENSION, DELAYED RELEASE;ORAL; EQ 5MG BASE/PACKET
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 5MG BASE/PACKET FOR SUSPENSION, DELAYED RELEASE;ORAL Prescription No AB 218948 AUROBINDO PHARMA LTD
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 5MG BASE/PACKET FOR SUSPENSION, DELAYED RELEASE;ORAL Prescription No AB 217714 CIPLA
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 5MG BASE/PACKET FOR SUSPENSION, DELAYED RELEASE;ORAL Prescription No AB 212651 TORRENT
NEXIUM ESOMEPRAZOLE MAGNESIUM EQ 5MG BASE/PACKET FOR SUSPENSION, DELAYED RELEASE;ORAL Prescription Yes AB 021957 ASTRAZENECA

FOR SUSPENSION, DELAYED RELEASE;ORAL; EQ 20MG BASE/PACKET
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE/PACKET FOR SUSPENSION, DELAYED RELEASE;ORAL Prescription No AB 218948 AUROBINDO PHARMA LTD
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE/PACKET FOR SUSPENSION, DELAYED RELEASE;ORAL Prescription No AB 211751 CIPLA
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE/PACKET FOR SUSPENSION, DELAYED RELEASE;ORAL Prescription No AB 212651 TORRENT
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE/PACKET FOR SUSPENSION, DELAYED RELEASE;ORAL Prescription No AB 206055 ZYDUS PHARMS
NEXIUM ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE/PACKET FOR SUSPENSION, DELAYED RELEASE;ORAL Prescription Yes AB 021957 ASTRAZENECA

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 40MG BASE/PACKET FOR SUSPENSION, DELAYED RELEASE;ORAL Prescription No AB 218948 AUROBINDO PHARMA LTD
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 40MG BASE/PACKET FOR SUSPENSION, DELAYED RELEASE;ORAL Prescription No AB 211751 CIPLA
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 40MG BASE/PACKET FOR SUSPENSION, DELAYED RELEASE;ORAL Prescription No AB 212651 TORRENT
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 40MG BASE/PACKET FOR SUSPENSION, DELAYED RELEASE;ORAL Prescription No AB 206055 ZYDUS PHARMS
NEXIUM ESOMEPRAZOLE MAGNESIUM EQ 40MG BASE/PACKET FOR SUSPENSION, DELAYED RELEASE;ORAL Prescription Yes AB 021957 ASTRAZENECA
Back to Top