Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 087102
Company: SUN PHARMA CANADA

Products on ANDA 087102

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLUOCINOLONE ACETONIDE	FLUOCINOLONE ACETONIDE	0.01%	CREAM;TOPICAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 087102

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/27/1982	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
07/31/1996	SUPPL-29	Labeling		Label is not available on this site.
03/29/1993	SUPPL-28	Labeling		Label is not available on this site.
03/29/1993	SUPPL-27	Labeling		Label is not available on this site.
11/16/1992	SUPPL-26	Labeling		Label is not available on this site.
03/15/1991	SUPPL-24	Labeling		Label is not available on this site.
01/07/1991	SUPPL-23	Labeling		Label is not available on this site.
09/19/1989	SUPPL-21	Labeling		Label is not available on this site.
01/03/1990	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
03/13/1992	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
11/25/1988	SUPPL-18	Labeling		Label is not available on this site.
10/07/1986	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
01/10/1986	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
06/12/1984	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
03/29/1984	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
06/15/1983	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
01/03/1983	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.