Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 200812
Company: STRIDES PHARMA
Company: STRIDES PHARMA
| 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 |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 11/10/2011 | ORIG-1 | Approval | Not Applicable |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/200812Orig1s000.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/15/2023 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/01/2023 | SUPPL-14 | Labeling-Medication Guide, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 09/18/2018 | SUPPL-13 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 12/01/2023 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/26/2017 | SUPPL-11 | REMS-Modified |
Label is not available on this site. |
||
| 09/30/2016 | SUPPL-10 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 04/20/2016 | SUPPL-8 | REMS-Modified |
Label is not available on this site. |
||
| 06/26/2015 | SUPPL-6 | REMS-Modified |
Label is not available on this site. |
||
| 08/19/2014 | SUPPL-5 | REMS-Modified |
Label is not available on this site. |
||
| 02/06/2015 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/24/2013 | SUPPL-2 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |