Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 201187
Company: EPIC PHARMA LLC
Company: EPIC PHARMA LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | AB | No | No |
| OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 12/15/2014 | ORIG-1 | Approval | Not Applicable |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/23/2025 | SUPPL-15 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 11/17/2025 | SUPPL-14 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/31/2024 | SUPPL-13 | REMS-Modified |
Label is not available on this site. |
||
| 12/15/2023 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/13/2023 | SUPPL-11 | Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 03/04/2021 | SUPPL-10 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 02/16/2021 | SUPPL-7 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 02/16/2021 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/18/2018 | SUPPL-4 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
||
| 02/16/2021 | SUPPL-2 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
OXYMORPHONE HYDROCHLORIDE
TABLET;ORAL; 5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 210175 | ASCENT PHARMS INC |
| OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 204459 | AUROLIFE PHARMA LLC |
| OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 203601 | AVANTHI INC |
| OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 201187 | EPIC PHARMA LLC |
| OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 090964 | HIKMA |
| OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 091443 | TEVA |
TABLET;ORAL; 10MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 210175 | ASCENT PHARMS INC |
| OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 204459 | AUROLIFE PHARMA LLC |
| OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 203601 | AVANTHI INC |
| OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 201187 | EPIC PHARMA LLC |
| OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 090964 | HIKMA |
| OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 091443 | TEVA |