Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 207193
Company: PERRIGO R AND D
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE;ORAL Over-the-counter None 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
08/18/2017 ORIG-1 Approval STANDARD Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207193Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207193Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/21/2020 SUPPL-11 Labeling-Container/Carton Labels, Labeling-Package Insert Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/207193Orig1s003s011.pdf
01/21/2020 SUPPL-3 Labeling-Package Insert, Labeling-Container/Carton Labels Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/207193Orig1s003s011.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/18/2017 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207193Orig1s000lbl.pdf

ESOMEPRAZOLE MAGNESIUM

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

CAPSULE, DELAYED RELEASE;ORAL; EQ 20MG BASE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE;ORAL Over-the-counter No 209716 AMNEAL PHARMS NY
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE;ORAL Over-the-counter No 209339 AUROBINDO PHARMA LTD
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE;ORAL Over-the-counter No 207673 DR REDDYS LABS LTD
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE;ORAL Over-the-counter No 208939 HETERO LABS LTD III
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE;ORAL Over-the-counter No 212507 HETERO LABS LTD III
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE;ORAL Over-the-counter No 207193 PERRIGO R AND D
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE;ORAL Over-the-counter No 212866 SUN PHARM
NEXIUM 24HR ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE;ORAL Over-the-counter Yes 204655 ASTRAZENECA LP

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English