Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078110
Company: PRINSTON INC
Company: PRINSTON INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 0.25MG BASE | TABLET;ORAL | Prescription | AB | No | Yes |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 0.5MG BASE | TABLET;ORAL | Prescription | AB | No | No |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 1MG BASE | TABLET;ORAL | Prescription | AB | No | No |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 2MG BASE | TABLET;ORAL | Prescription | AB | No | No |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 3MG BASE | TABLET;ORAL | Prescription | AB | No | No |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 4MG BASE | TABLET;ORAL | Prescription | AB | No | No |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 5MG BASE | 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 |
|---|---|---|---|---|---|---|---|
| 05/05/2008 | 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 |
|---|---|---|---|---|---|
| 09/16/2025 | SUPPL-21 | Labeling-Medication Guide, Labeling-Patient Package Insert, Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/16/2025 | SUPPL-20 | Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 09/16/2025 | SUPPL-18 | Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 02/21/2020 | SUPPL-17 | Labeling-Medication Guide, Labeling-Patient Package Insert, Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 02/21/2020 | SUPPL-14 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 02/21/2020 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/11/2015 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/13/2015 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/11/2015 | SUPPL-6 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 07/11/2008 | SUPPL-1 | Labeling |
Label is not available on this site. |
ROPINIROLE HYDROCHLORIDE
TABLET;ORAL; EQ 0.25MG 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 0.25MG BASE | TABLET;ORAL | Prescription | No | AB | 204022 | ACCORD HLTHCARE |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 0.25MG BASE | TABLET;ORAL | Prescription | No | AB | 090429 | ALEMBIC LTD |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 0.25MG BASE | TABLET;ORAL | Prescription | No | AB | 079050 | CHARTWELL RX |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 0.25MG BASE | TABLET;ORAL | Prescription | No | AB | 090135 | GLENMARK PHARMS LTD |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 0.25MG BASE | TABLET;ORAL | Prescription | No | AB | 079165 | MLV |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 0.25MG BASE | TABLET;ORAL | Prescription | No | AB | 079229 | ORBION PHARMS |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 0.25MG BASE | TABLET;ORAL | Prescription | No | AB | 078110 | PRINSTON INC |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 0.25MG BASE | TABLET;ORAL | Prescription | No | AB | 090411 | ZYDUS LIFESCIENCES |
TABLET;ORAL; EQ 0.5MG 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 0.5MG BASE | TABLET;ORAL | Prescription | No | AB | 204022 | ACCORD HLTHCARE |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 0.5MG BASE | TABLET;ORAL | Prescription | No | AB | 090429 | ALEMBIC LTD |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 0.5MG BASE | TABLET;ORAL | Prescription | No | AB | 079050 | CHARTWELL RX |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 0.5MG BASE | TABLET;ORAL | Prescription | No | AB | 090135 | GLENMARK PHARMS LTD |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 0.5MG BASE | TABLET;ORAL | Prescription | No | AB | 079165 | MLV |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 0.5MG BASE | TABLET;ORAL | Prescription | No | AB | 079229 | ORBION PHARMS |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 0.5MG BASE | TABLET;ORAL | Prescription | No | AB | 078110 | PRINSTON INC |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 0.5MG BASE | TABLET;ORAL | Prescription | No | AB | 090411 | ZYDUS LIFESCIENCES |
TABLET;ORAL; EQ 1MG 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 1MG BASE | TABLET;ORAL | Prescription | No | AB | 204022 | ACCORD HLTHCARE |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 090429 | ALEMBIC LTD |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 079050 | CHARTWELL RX |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 090135 | GLENMARK PHARMS LTD |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 079165 | MLV |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 079229 | ORBION PHARMS |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 078110 | PRINSTON INC |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 090411 | ZYDUS LIFESCIENCES |
TABLET;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;ORAL | Prescription | No | AB | 204022 | ACCORD HLTHCARE |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 2MG BASE | TABLET;ORAL | Prescription | No | AB | 090429 | ALEMBIC LTD |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 2MG BASE | TABLET;ORAL | Prescription | No | AB | 079050 | CHARTWELL RX |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 2MG BASE | TABLET;ORAL | Prescription | No | AB | 090135 | GLENMARK PHARMS LTD |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 2MG BASE | TABLET;ORAL | Prescription | No | AB | 079165 | MLV |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 2MG BASE | TABLET;ORAL | Prescription | No | AB | 079229 | ORBION PHARMS |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 2MG BASE | TABLET;ORAL | Prescription | No | AB | 078110 | PRINSTON INC |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 2MG BASE | TABLET;ORAL | Prescription | No | AB | 090411 | ZYDUS LIFESCIENCES |
TABLET;ORAL; EQ 3MG 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 3MG BASE | TABLET;ORAL | Prescription | No | AB | 204022 | ACCORD HLTHCARE |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 3MG BASE | TABLET;ORAL | Prescription | No | AB | 090429 | ALEMBIC LTD |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 3MG BASE | TABLET;ORAL | Prescription | No | AB | 079050 | CHARTWELL RX |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 3MG BASE | TABLET;ORAL | Prescription | No | AB | 090135 | GLENMARK PHARMS LTD |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 3MG BASE | TABLET;ORAL | Prescription | No | AB | 079165 | MLV |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 3MG BASE | TABLET;ORAL | Prescription | No | AB | 079229 | ORBION PHARMS |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 3MG BASE | TABLET;ORAL | Prescription | No | AB | 078110 | PRINSTON INC |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 3MG BASE | TABLET;ORAL | Prescription | No | AB | 090411 | ZYDUS LIFESCIENCES |
TABLET;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;ORAL | Prescription | No | AB | 204022 | ACCORD HLTHCARE |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 4MG BASE | TABLET;ORAL | Prescription | No | AB | 090429 | ALEMBIC LTD |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 4MG BASE | TABLET;ORAL | Prescription | No | AB | 079050 | CHARTWELL RX |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 4MG BASE | TABLET;ORAL | Prescription | No | AB | 090135 | GLENMARK PHARMS LTD |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 4MG BASE | TABLET;ORAL | Prescription | No | AB | 079165 | MLV |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 4MG BASE | TABLET;ORAL | Prescription | No | AB | 079229 | ORBION PHARMS |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 4MG BASE | TABLET;ORAL | Prescription | No | AB | 078110 | PRINSTON INC |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 4MG BASE | TABLET;ORAL | Prescription | No | AB | 090411 | ZYDUS LIFESCIENCES |
TABLET;ORAL; EQ 5MG 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 5MG BASE | TABLET;ORAL | Prescription | No | AB | 204022 | ACCORD HLTHCARE |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 090429 | ALEMBIC LTD |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 079050 | CHARTWELL RX |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 090135 | GLENMARK PHARMS LTD |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 079165 | MLV |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 079229 | ORBION PHARMS |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 078110 | PRINSTON INC |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 090411 | ZYDUS LIFESCIENCES |