Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090964
Company: HIKMA
Company: HIKMA
| 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 |
|---|---|---|---|---|---|---|---|
| 09/27/2010 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/19/2024 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/04/2021 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/08/2021 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/08/2021 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/18/2018 | SUPPL-6 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
||
| 02/08/2021 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/25/2015 | SUPPL-2 | 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 |