U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 211751
Company: CIPLA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
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
03/23/2020 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211751Orig1s000ltr.pdf

ESOMEPRAZOLE MAGNESIUM

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 211751 CIPLA
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 211751 CIPLA
NEXIUM ESOMEPRAZOLE MAGNESIUM EQ 40MG BASE/PACKET FOR SUSPENSION, DELAYED RELEASE;ORAL Prescription Yes AB 021957 ASTRAZENECA
Back to Top