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Abbreviated New Drug Application (ANDA): 206877
Company: AUROBINDO PHARMA
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
OMEPRAZOLE MAGNESIUM OMEPRAZOLE MAGNESIUM EQ 20MG BASE TABLET, DELAYED RELEASE;ORAL Over-the-counter No 211732 HETERO LABS LTD III
OMEPRAZOLE MAGNESIUM OMEPRAZOLE MAGNESIUM EQ 20MG BASE TABLET, DELAYED RELEASE;ORAL Over-the-counter No 206582 P AND L
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
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