Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019977
Company: XANODYNE PHARMS INC
Company: XANODYNE PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ORAMORPH SR | MORPHINE SULFATE | 30MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| ORAMORPH SR | MORPHINE SULFATE | 60MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| ORAMORPH SR | MORPHINE SULFATE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| ORAMORPH SR | 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 |
|---|---|---|---|---|---|---|---|
| 08/15/1991 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/13/2001 | SUPPL-7 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19977s4s7ltr.pdf |
| 11/23/1994 | SUPPL-5 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 07/13/2001 | SUPPL-4 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19977s4s7ltr.pdf |
| 03/11/1994 | SUPPL-3 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 04/18/1994 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |