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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211732
Company: HETERO LABS LTD III
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
03/25/2020 ORIG-1 Approval STANDARD

Label is not available on this site.

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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