Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 206877
Company: AUROBINDO PHARMA LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OMEPRAZOLE MAGNESIUM OMEPRAZOLE MAGNESIUM EQ 20MG BASE TABLET, 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
06/06/2018 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206877Orig1s000TAltr.pdf

OMEPRAZOLE MAGNESIUM

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

TABLET, DELAYED RELEASE;ORAL; EQ 20MG BASE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
OMEPRAZOLE MAGNESIUM OMEPRAZOLE MAGNESIUM EQ 20MG BASE TABLET, DELAYED RELEASE;ORAL Over-the-counter No 206877 AUROBINDO PHARMA LTD
OMEPRAZOLE MAGNESIUM OMEPRAZOLE MAGNESIUM EQ 20MG BASE TABLET, DELAYED RELEASE;ORAL Over-the-counter No 204152 PERRIGO R AND D
PRILOSEC OTC OMEPRAZOLE MAGNESIUM EQ 20MG BASE TABLET, DELAYED RELEASE;ORAL Over-the-counter Yes 021229 ASTRAZENECA PHARMS

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