Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090764
Company: MYLAN

Products on ANDA 090764

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090764

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/09/2010	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-13	Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
03/19/2024	SUPPL-11	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
03/19/2024	SUPPL-10	Labeling-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.
11/05/2015	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
11/05/2015	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
08/08/2013	SUPPL-4	Labeling-Container/Carton Labels		Label is not available on this site.