Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 213444
Company: NOVAST LABS
Company: NOVAST LABS
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 |
---|---|---|---|---|---|---|---|
02/03/2022 | ORIG-1 | Approval | STANDARD |
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 |