Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091498
Company: CSPC OUYI PHARM CO
Company: CSPC OUYI PHARM CO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | 50MG | 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 |
|---|---|---|---|---|---|---|---|
| 03/29/2013 | 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 |
|---|---|---|---|---|---|
| 12/29/2025 | SUPPL-16 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/31/2024 | SUPPL-15 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 10/21/2025 | SUPPL-14 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 12/15/2023 | SUPPL-13 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/18/2023 | SUPPL-12 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 07/30/2021 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/30/2021 | SUPPL-10 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 07/30/2021 | SUPPL-9 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 07/30/2021 | SUPPL-8 | Labeling-Package Insert, Labeling-Medication Guide, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 09/18/2018 | SUPPL-7 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
||
| 07/30/2021 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/30/2021 | SUPPL-5 | Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/05/2014 | SUPPL-1 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
TRAMADOL HYDROCHLORIDE
TABLET;ORAL; 50MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 076003 | AMNEAL PHARMS |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 203494 | AUROBINDO PHARMA LTD |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 091498 | CSPC OUYI PHARM CO |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 075968 | GRAVITI PHARMS |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 208708 | RUBICON RESEARCH |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 090404 | SENORES PHARMS |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 202075 | STRIDES PHARMA |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 075964 | SUN PHARM INDS INC |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 075977 | TEVA |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 211825 | UNICHEM |