Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090190
Company: SANDOZ
Company: SANDOZ
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.125MG | TABLET;ORAL | Discontinued | None | No | No |
PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.25MG | TABLET;ORAL | Discontinued | None | No | No |
PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.5MG | TABLET;ORAL | Discontinued | None | No | No |
PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1MG | TABLET;ORAL | Discontinued | None | No | No |
PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET;ORAL | Discontinued | None | No | No |
PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET;ORAL | Discontinued | None | 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 |
---|---|---|---|---|---|---|---|
10/08/2010 | ORIG-2 | Approval |
Label is not available on this site. |
||||
07/06/2010 | 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 |
---|---|---|---|---|---|
05/11/2016 | SUPPL-14 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
10/26/2015 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
08/19/2013 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
08/19/2013 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
09/29/2011 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |