Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203506
Company: SUN PHARM INDS LTD
Company: SUN PHARM INDS LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | 5MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | 7.5MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | 10MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | 15MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | 20MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | 30MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | 40MG | 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 |
|---|---|---|---|---|---|---|---|
| 04/24/2015 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203506Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/26/2017 | SUPPL-7 | REMS-Modified |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-5 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 09/30/2016 | SUPPL-4 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/20/2016 | SUPPL-2 | REMS-Modified |
Label is not available on this site. |
||
| 06/26/2015 | SUPPL-1 | REMS-Proposal |
Label is not available on this site. |