Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 090190
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.

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English