Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 080472
Company: VALEANT INTL

Products on ANDA 080472

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYTONE	HYDROCORTISONE	1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	CREAM;TOPICAL	Discontinued	None	Yes	No
HYTONE	HYDROCORTISONE	2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	CREAM;TOPICAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 080472

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/27/1972	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
03/27/2002	SUPPL-30	Manufacturing (CMC)-Facility		Label is not available on this site.
01/27/1992	SUPPL-28	Manufacturing (CMC)		Label is not available on this site.
01/27/1992	SUPPL-27	Manufacturing (CMC)		Label is not available on this site.
03/15/1985	SUPPL-25	Manufacturing (CMC)		Label is not available on this site.
11/15/1983	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
11/15/1983	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
07/08/1983	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
02/26/1982	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
04/08/1982	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
04/08/1982	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
04/08/1982	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.