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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 085691
Company: FOUGERA PHARMS

Products on ANDA 085691

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT;TOPICAL	Prescription	AT	No	No
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT;TOPICAL	Prescription	AT	No	No
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT;TOPICAL	Prescription	AT	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 085691

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/09/1978	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
08/23/2004	SUPPL-35	Labeling		Label is not available on this site.
03/07/1996	SUPPL-33	Manufacturing (CMC)		Label is not available on this site.
12/30/1994	SUPPL-32	Manufacturing (CMC)		Label is not available on this site.
05/20/1988	SUPPL-31	Manufacturing (CMC)		Label is not available on this site.
03/25/1988	SUPPL-30	Labeling		Label is not available on this site.
07/31/1987	SUPPL-29	Manufacturing (CMC)		Label is not available on this site.
05/20/1988	SUPPL-27	Manufacturing (CMC)		Label is not available on this site.
09/25/1986	SUPPL-26	Manufacturing (CMC)		Label is not available on this site.
05/04/1983	SUPPL-25	Manufacturing (CMC)		Label is not available on this site.
05/04/1983	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
10/28/1982	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
07/27/1982	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
07/27/1982	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
07/27/1982	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
07/27/1982	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
07/27/1982	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 085691

TRIAMCINOLONE ACETONIDE

OINTMENT;TOPICAL; 0.025%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT;TOPICAL	Prescription	No	AT	089795	COSETTE
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT;TOPICAL	Prescription	No	AT	085691	FOUGERA PHARMS
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT;TOPICAL	Prescription	No	AT	209828	MACLEODS PHARMS LTD
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT;TOPICAL	Prescription	Yes	AT	087385	PADAGIS US

OINTMENT;TOPICAL; 0.5%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT;TOPICAL	Prescription	No	AT	085691	FOUGERA PHARMS
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT;TOPICAL	Prescription	No	AT	209828	MACLEODS PHARMS LTD
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT;TOPICAL	Prescription	Yes	AT	087385	PADAGIS US

OINTMENT;TOPICAL; 0.1%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT;TOPICAL	Prescription	No	AT	207365	CHARTWELL RX
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT;TOPICAL	Prescription	No	AT	089796	COSETTE
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT;TOPICAL	Prescription	No	AT	205373	ENCUBE
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT;TOPICAL	Prescription	No	AT	085691	FOUGERA PHARMS
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT;TOPICAL	Prescription	No	AT	209828	MACLEODS PHARMS LTD
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT;TOPICAL	Prescription	Yes	AT	087385	PADAGIS US
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT;TOPICAL	Prescription	No	AT	040037	SUN PHARMA CANADA

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