Drugs@FDA: FDA-Approved Drugs
Company: DR REDDYS LABS LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OMEPRAZOLE MAGNESIUM | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE;ORAL | Over-the-counter | None | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
06/05/2009 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/078878Orig1s000.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/02/2023 | SUPPL-42 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
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06/02/2023 | SUPPL-32 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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06/02/2023 | SUPPL-30 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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06/02/2023 | SUPPL-28 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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06/08/2016 | SUPPL-22 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
02/14/2014 | SUPPL-15 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
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10/31/2013 | SUPPL-12 | Labeling-Container/Carton Labels |
Label is not available on this site. |
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08/27/2012 | SUPPL-11 | Labeling-Container/Carton Labels |
Label is not available on this site. |
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04/06/2015 | SUPPL-10 | Labeling-Container/Carton Labels |
Label is not available on this site. |
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11/23/2010 | SUPPL-6 | Labeling-Package Insert |
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.
CAPSULE, 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 | CAPSULE, DELAYED RELEASE;ORAL | Over-the-counter | No | 078878 | DR REDDYS LABS LTD |
OMEPRAZOLE MAGNESIUM | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE;ORAL | Over-the-counter | No | 216096 | L PERRIGO CO |
OMEPRAZOLE MAGNESIUM | OMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE;ORAL | Over-the-counter | No | 210593 | SPIL |