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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 062279
Company: VALEANT LUXEMBOURG

Products on ANDA 062279

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GRIFULVIN V	GRISEOFULVIN, MICROCRYSTALLINE	125MG	TABLET;ORAL	Discontinued	None	No	No
GRIFULVIN V	GRISEOFULVIN, MICROCRYSTALLINE	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	No	No
GRIFULVIN V	GRISEOFULVIN, MICROSIZE	500MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 062279

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/02/1980	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
04/22/2014	SUPPL-22	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/062279s022lbl.pdf
08/08/1997	SUPPL-16		Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/62483S013.pdf
02/16/1993	SUPPL-15	Labeling		Label is not available on this site.
01/27/1992	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
01/27/1992	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
03/22/1990	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
11/02/1990	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
11/17/1988	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
01/27/1992	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.

Labels for ANDA 062279

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/22/2014	SUPPL-22	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/062279s022lbl.pdf

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