Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 211732
Company: HETERO LABS LTD III
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 |
PRILOSEC OTC | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE;ORAL | Over-the-counter | Yes | 021229 | ASTRAZENECA |