Drugs@FDA: FDA-Approved Drugs
Company: IMPAX LABS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MORPHINE SULFATE | MORPHINE SULFATE | 20MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
MORPHINE SULFATE | MORPHINE SULFATE | 30MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
MORPHINE SULFATE | MORPHINE SULFATE | 50MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
MORPHINE SULFATE | MORPHINE SULFATE | 60MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
MORPHINE SULFATE | MORPHINE SULFATE | 80MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
MORPHINE SULFATE | MORPHINE SULFATE | 100MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
MORPHINE SULFATE | MORPHINE SULFATE | 40MG | CAPSULE, 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 |
---|---|---|---|---|---|---|---|
04/12/2016 | ORIG-1 | Approval | Not Applicable |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/15/2023 | SUPPL-23 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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12/15/2023 | SUPPL-22 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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12/06/2023 | SUPPL-21 | Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide |
Label is not available on this site. |
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12/06/2023 | SUPPL-20 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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12/06/2023 | SUPPL-18 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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12/06/2023 | SUPPL-14 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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09/18/2018 | SUPPL-10 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
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05/26/2017 | SUPPL-6 | REMS-Modified |
Label is not available on this site. |
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07/19/2018 | SUPPL-5 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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05/19/2017 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
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09/30/2016 | SUPPL-3 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
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04/20/2016 | SUPPL-1 | REMS-Modified |
Label is not available on this site. |