Drugs@FDA: FDA Approved Drug Products
Abbreviated New Drug Application (ANDA): 091395
Company: WOCKHARDT LTD
Company: WOCKHARDT LTD
| 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 |
|---|---|---|---|---|---|---|---|
| 08/27/2012 | ORIG-1 | Approval |
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 |
|---|---|---|---|---|---|---|---|---|
| REQUIP XL | ROPINIROLE HYDROCHLORIDE | EQ 2MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 022008 | GLAXOSMITHKLINE LLC |
| 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 PHARMS LTD |
| 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 | 201047 | SANDOZ INC |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 2MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 200431 | WATSON LABS INC |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 2MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 091395 | WOCKHARDT LTD |
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 |
|---|---|---|---|---|---|---|---|---|
| REQUIP XL | ROPINIROLE HYDROCHLORIDE | EQ 4MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 022008 | GLAXOSMITHKLINE LLC |
| 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 PHARMS LTD |
| 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 | 201047 | SANDOZ INC |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 4MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 200431 | WATSON LABS INC |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 4MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 091395 | WOCKHARDT LTD |
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 |
|---|---|---|---|---|---|---|---|---|
| REQUIP XL | ROPINIROLE HYDROCHLORIDE | EQ 6MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 022008 | GLAXOSMITHKLINE LLC |
| 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 PHARMS LTD |
| 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 | 201047 | SANDOZ INC |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 6MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 200431 | WATSON LABS INC |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 6MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 091395 | WOCKHARDT LTD |
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 |
|---|---|---|---|---|---|---|---|---|
| REQUIP XL | ROPINIROLE HYDROCHLORIDE | EQ 8MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 022008 | GLAXOSMITHKLINE LLC |
| 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 PHARMS LTD |
| 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 | 201047 | SANDOZ INC |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 8MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 200431 | WATSON LABS INC |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 8MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 091395 | WOCKHARDT LTD |
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 |
|---|---|---|---|---|---|---|---|---|
| REQUIP XL | ROPINIROLE HYDROCHLORIDE | EQ 12MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 022008 | GLAXOSMITHKLINE LLC |
| 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 PHARMS LTD |
| 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 | 201047 | SANDOZ INC |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 12MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 200431 | WATSON LABS INC |
| ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 12MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 091395 | WOCKHARDT LTD |
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