Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203602
Company: NOVEL LABS INC
Company: NOVEL LABS INC
| 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 |
| MORPHINE SULFATE | MORPHINE SULFATE | 30MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| MORPHINE SULFATE | MORPHINE SULFATE | 60MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| MORPHINE SULFATE | MORPHINE SULFATE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| MORPHINE SULFATE | MORPHINE SULFATE | 200MG | 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 |
|---|---|---|---|---|---|---|---|
| 12/16/2015 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203602Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/03/2025 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/31/2024 | SUPPL-10 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 02/03/2025 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/03/2025 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/18/2018 | SUPPL-7 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 05/26/2017 | SUPPL-6 | REMS-Modified |
Label is not available on this site. |
||
| 02/03/2025 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/30/2016 | SUPPL-4 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 02/03/2025 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/20/2016 | SUPPL-1 | REMS-Modified |
Label is not available on this site. |