Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076699
Company: UCB INC

Products on ANDA 076699

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PARCOPA	CARBIDOPA; LEVODOPA	10MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET, ORALLY DISINTEGRATING;ORAL	Discontinued	None	No	No
PARCOPA	CARBIDOPA; LEVODOPA	25MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET, ORALLY DISINTEGRATING;ORAL	Discontinued	None	No	No
PARCOPA	CARBIDOPA; LEVODOPA	25MG;250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET, ORALLY DISINTEGRATING;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076699

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/27/2004	ORIG-1	Approval			Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76699ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076699_S000_PARCOPATOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/30/2010	SUPPL-4	Labeling-Package Insert		Label is not available on this site.