Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203615
Company: ACTAVIS ELIZABETH
Company: ACTAVIS ELIZABETH
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 2.25MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 3.75MG | 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 |
---|---|---|---|---|---|---|---|
01/03/2017 | ORIG-2 | Approval |
Label is not available on this site. |
||||
10/14/2016 | 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-3 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
PRAMIPEXOLE DIHYDROCHLORIDE
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 |
---|---|---|---|---|---|---|---|---|
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; 3.75MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
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 |