Drugs@FDA: FDA-Approved Drugs
Company: NESHER PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MORPHINE SULFATE | MORPHINE SULFATE | 60MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
MORPHINE SULFATE | MORPHINE SULFATE | 30MG | 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-25 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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12/10/2019 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
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09/18/2018 | SUPPL-23 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
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12/10/2019 | SUPPL-22 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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05/26/2017 | SUPPL-21 | REMS-Modified |
Label is not available on this site. |
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09/30/2016 | SUPPL-20 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
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04/20/2016 | SUPPL-19 | REMS-Modified |
Label is not available on this site. |
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06/26/2015 | SUPPL-17 | REMS-Modified |
Label is not available on this site. |
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05/08/2015 | SUPPL-13 | Labeling-Medication Guide, REMS-Proposal |
Label is not available on this site. |
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04/22/2015 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
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01/10/2008 | SUPPL-7 | Labeling |
Label is not available on this site. |
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12/23/2005 | SUPPL-2 | Labeling |
Label is not available on this site. |