Drugs@FDA: FDA-Approved Drugs
Company: ACTAVIS ELIZABETH
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 | 3MG | 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 |
---|---|---|---|---|---|---|---|
04/21/2016 | ORIG-1 | Approval | Not Applicable |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/16/2023 | SUPPL-6 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
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10/15/2020 | SUPPL-4 | Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Patient Package Insert |
Label is not available on this site. |
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10/15/2020 | SUPPL-2 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
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10/15/2020 | SUPPL-1 | 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 |
---|---|---|---|---|---|---|---|---|
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 |
---|---|---|---|---|---|---|---|---|
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 |
---|---|---|---|---|---|---|---|---|
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; 3MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
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; 4.5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
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 |