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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211752
Company: CIPLA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 10MG 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/2020/211752Orig1s000ltr.pdf

ESOMEPRAZOLE MAGNESIUM

FOR SUSPENSION, DELAYED RELEASE;ORAL; EQ 10MG 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 10MG BASE/PACKET FOR SUSPENSION, DELAYED RELEASE;ORAL Prescription No AB 211752 CIPLA
NEXIUM ESOMEPRAZOLE MAGNESIUM EQ 10MG BASE/PACKET FOR SUSPENSION, DELAYED RELEASE;ORAL Prescription Yes AB 022101 ASTRAZENECA
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