Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076733
Company: NESHER PHARMS
Company: NESHER PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MORPHINE SULFATE | MORPHINE SULFATE | 15MG | TABLET, EXTENDED RELEASE;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 |
|---|---|---|---|---|---|---|---|
| 05/19/2004 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/10/2019 | SUPPL-24 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 12/10/2019 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/18/2018 | SUPPL-22 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 12/10/2019 | SUPPL-21 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 05/26/2017 | SUPPL-20 | REMS-Modified |
Label is not available on this site. |
||
| 09/30/2016 | SUPPL-19 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 04/20/2016 | SUPPL-18 | REMS-Modified |
Label is not available on this site. |
||
| 06/26/2015 | SUPPL-16 | REMS-Modified |
Label is not available on this site. |
||
| 05/08/2015 | SUPPL-12 | Labeling-Medication Guide, REMS-Proposal |
Label is not available on this site. |
||
| 04/22/2015 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/10/2008 | SUPPL-7 | Labeling |
Label is not available on this site. |