Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 077854
Company: MYLAN

Products on ANDA 077854

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077854

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-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
03/19/2024	SUPPL-11	Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
03/19/2024	SUPPL-9	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
03/19/2024	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
03/19/2024	SUPPL-7	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
03/19/2024	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
03/19/2024	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
08/08/2013	SUPPL-2	Labeling-Package Insert		Label is not available on this site.