Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090241
Company: CHARTWELL RX

Products on ANDA 090241

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	0.75MG	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 090241

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
03/27/2024	SUPPL-5	Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
03/10/2021	SUPPL-4	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
03/10/2021	SUPPL-3	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
03/10/2021	SUPPL-2	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
06/14/2011	SUPPL-1	Labeling-Container/Carton Labels		Label is not available on this site.