Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209404
Company: MACLEODS PHARMS
Company: MACLEODS PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB1 | No | No |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB1 | No | No |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB1 | 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 |
|---|---|---|---|---|---|---|---|
| 01/31/2025 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/18/2026 | SUPPL-3 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 12/29/2025 | SUPPL-2 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
TRAMADOL HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL; 100MG
TE Code = AB1
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 200503 | LUPIN LTD |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 209404 | MACLEODS PHARMS |
TABLET, EXTENDED RELEASE;ORAL; 200MG
TE Code = AB1
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 200503 | LUPIN LTD |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 209404 | MACLEODS PHARMS |
TABLET, EXTENDED RELEASE;ORAL; 300MG
TE Code = AB1
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 200503 | LUPIN LTD |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 209404 | MACLEODS PHARMS |