Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077460
Company: COSETTE

Products on ANDA 077460

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 0.25MG BASE	TABLET;ORAL	Discontinued	None	No	No
ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 0.5MG BASE	TABLET;ORAL	Discontinued	None	No	No
ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 1MG BASE	TABLET;ORAL	Discontinued	None	No	No
ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 2MG BASE	TABLET;ORAL	Discontinued	None	No	No
ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 3MG BASE	TABLET;ORAL	Discontinued	None	No	No
ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 4MG BASE	TABLET;ORAL	Discontinued	None	No	No
ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE	EQ 5MG BASE	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077460

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/05/2008	ORIG-1	Approval			Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/077460s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077460s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/03/2020	SUPPL-8	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/17/2009	SUPPL-4	Labeling		Label is not available on this site.
05/19/2008	SUPPL-2	Labeling		Label is not available on this site.

Labels for ANDA 077460

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/05/2008	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/077460s000lbl.pdf