Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202786
Company: ALEMBIC
Company: ALEMBIC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 2MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 4MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 6MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 8MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 12MG BASE | TABLET, EXTENDED RELEASE;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 |
|---|---|---|---|---|---|---|---|
| 04/22/2013 | 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 |
|---|---|---|---|---|---|
| 11/19/2025 | SUPPL-21 | Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 01/10/2016 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/10/2016 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
ROPINIROLE HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL; EQ 2MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 2MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 090869 | ACTAVIS ELIZABETH |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 2MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202786 | ALEMBIC |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 2MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 091395 | CHARTWELL RX |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 2MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 201576 | DR REDDYS LABS LTD |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 2MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 217862 | ELITE LABS INC |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 2MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204413 | PRINSTON INC |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 2MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 201047 | SANDOZ INC |
TABLET, EXTENDED RELEASE;ORAL; EQ 4MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 4MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 090869 | ACTAVIS ELIZABETH |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 4MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202786 | ALEMBIC |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 4MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 091395 | CHARTWELL RX |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 4MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 201576 | DR REDDYS LABS LTD |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 4MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 217862 | ELITE LABS INC |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 4MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204413 | PRINSTON INC |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 4MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 201047 | SANDOZ INC |
TABLET, EXTENDED RELEASE;ORAL; EQ 6MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 6MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 090869 | ACTAVIS ELIZABETH |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 6MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202786 | ALEMBIC |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 6MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 091395 | CHARTWELL RX |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 6MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 201576 | DR REDDYS LABS LTD |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 6MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 217862 | ELITE LABS INC |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 6MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204413 | PRINSTON INC |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 6MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 201047 | SANDOZ INC |
TABLET, EXTENDED RELEASE;ORAL; EQ 8MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 8MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 090869 | ACTAVIS ELIZABETH |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 8MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202786 | ALEMBIC |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 8MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 091395 | CHARTWELL RX |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 8MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 201576 | DR REDDYS LABS LTD |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 8MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 217862 | ELITE LABS INC |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 8MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204413 | PRINSTON INC |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 8MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 201047 | SANDOZ INC |
TABLET, EXTENDED RELEASE;ORAL; EQ 12MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 12MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 090869 | ACTAVIS ELIZABETH |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 12MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202786 | ALEMBIC |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 12MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 091395 | CHARTWELL RX |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 12MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 201576 | DR REDDYS LABS LTD |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 12MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 217862 | ELITE LABS INC |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 12MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204413 | PRINSTON INC |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 12MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 201047 | SANDOZ INC |