Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075656
Company: WATSON LABS
Company: WATSON LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MORPHINE SULFATE | MORPHINE SULFATE | 100MG | 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 |
|---|---|---|---|---|---|---|---|
| 01/30/2001 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75656ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/075656.PDF |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/15/2015 | SUPPL-7 | Labeling-Package Insert, REMS-Modified |
Label is not available on this site. |
||
| 10/10/2003 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 07/15/2002 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/08/2002 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/27/2002 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |