Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204518
Company: ALEMBIC
Company: ALEMBIC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.375MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 2.25MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 3MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 3.75MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 4.5MG | 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 |
|---|---|---|---|---|---|---|---|
| 01/02/2019 | 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 |
|---|---|---|---|---|---|
| 05/31/2023 | SUPPL-6 | Labeling-Container/Carton Labels, Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
PRAMIPEXOLE DIHYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL; 0.375MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MIRAPEX ER | PRAMIPEXOLE DIHYDROCHLORIDE | 0.375MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 022421 | BOEHRINGER INGELHEIM |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.375MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 201963 | ACTAVIS ELIZABETH |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.375MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204518 | ALEMBIC |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.375MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203354 | DR REDDYS |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.375MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206156 | MACLEODS PHARMS LTD |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.375MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213444 | NOVAST LABS |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.375MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202353 | SANDOZ |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.375MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212797 | XIAMEN LP PHARM CO |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.375MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202891 | ZYDUS PHARMS |
TABLET, EXTENDED RELEASE;ORAL; 0.75MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MIRAPEX ER | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 022421 | BOEHRINGER INGELHEIM |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 201963 | ACTAVIS ELIZABETH |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204518 | ALEMBIC |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203354 | DR REDDYS |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206156 | MACLEODS PHARMS LTD |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213444 | NOVAST LABS |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202353 | SANDOZ |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212797 | XIAMEN LP PHARM CO |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202891 | ZYDUS PHARMS |
TABLET, EXTENDED RELEASE;ORAL; 1.5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MIRAPEX ER | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 022421 | BOEHRINGER INGELHEIM |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 201963 | ACTAVIS ELIZABETH |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204518 | ALEMBIC |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203354 | DR REDDYS |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206156 | MACLEODS PHARMS LTD |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213444 | NOVAST LABS |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202353 | SANDOZ |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202891 | ZYDUS PHARMS |
TABLET, EXTENDED RELEASE;ORAL; 2.25MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MIRAPEX ER | PRAMIPEXOLE DIHYDROCHLORIDE | 2.25MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 022421 | BOEHRINGER INGELHEIM |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 2.25MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203615 | ACTAVIS ELIZABETH |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 2.25MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204518 | ALEMBIC |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 2.25MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206156 | MACLEODS PHARMS LTD |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 2.25MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213444 | NOVAST LABS |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 2.25MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202891 | ZYDUS PHARMS |
TABLET, EXTENDED RELEASE;ORAL; 3MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MIRAPEX ER | PRAMIPEXOLE DIHYDROCHLORIDE | 3MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 022421 | BOEHRINGER INGELHEIM |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 3MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 201963 | ACTAVIS ELIZABETH |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 3MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204518 | ALEMBIC |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 3MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203354 | DR REDDYS |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 3MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206156 | MACLEODS PHARMS LTD |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 3MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213444 | NOVAST LABS |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 3MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202353 | SANDOZ |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 3MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202891 | ZYDUS PHARMS |
TABLET, EXTENDED RELEASE;ORAL; 3.75MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MIRAPEX ER | PRAMIPEXOLE DIHYDROCHLORIDE | 3.75MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 022421 | BOEHRINGER INGELHEIM |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 3.75MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203615 | ACTAVIS ELIZABETH |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 3.75MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204518 | ALEMBIC |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 3.75MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206156 | MACLEODS PHARMS LTD |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 3.75MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213444 | NOVAST LABS |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 3.75MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202891 | ZYDUS PHARMS |
TABLET, EXTENDED RELEASE;ORAL; 4.5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MIRAPEX ER | PRAMIPEXOLE DIHYDROCHLORIDE | 4.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 022421 | BOEHRINGER INGELHEIM |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 4.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 201963 | ACTAVIS ELIZABETH |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 4.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204518 | ALEMBIC |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 4.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203354 | DR REDDYS |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 4.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206156 | MACLEODS PHARMS LTD |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 4.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213444 | NOVAST LABS |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 4.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202353 | SANDOZ |
| PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 4.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202891 | ZYDUS PHARMS |