Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078966
Company: STRIDES PHARMA INTL
Company: STRIDES PHARMA INTL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| OMEPRAZOLE AND SODIUM BICARBONATE | OMEPRAZOLE; SODIUM BICARBONATE | 20MG;1.1GM | CAPSULE;ORAL | Discontinued | None | No | No |
| OMEPRAZOLE AND SODIUM BICARBONATE | OMEPRAZOLE; SODIUM BICARBONATE | 40MG;1.1GM | CAPSULE;ORAL | Discontinued | 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 |
|---|---|---|---|---|---|---|---|
| 05/25/2010 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/078966s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/19/2023 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/19/2023 | SUPPL-11 | Labeling-Medication Guide, Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 07/20/2020 | SUPPL-9 | Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 04/09/2015 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/27/2012 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/13/2012 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/13/2012 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/13/2012 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |