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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 085692
Company: FOUGERA PHARMS

Products on ANDA 085692

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.025%	CREAM;TOPICAL	Prescription	AT	Yes	Yes
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.5%	CREAM;TOPICAL	Prescription	AT	Yes	Yes
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.1%	CREAM;TOPICAL	Prescription	AT	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 085692

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
08/12/1997	SUPPL-52	Manufacturing (CMC)		Label is not available on this site.
03/07/1996	SUPPL-51	Manufacturing (CMC)		Label is not available on this site.
05/09/1995	SUPPL-50	Manufacturing (CMC)		Label is not available on this site.
06/01/1995	SUPPL-49	Manufacturing (CMC)		Label is not available on this site.
08/24/1993	SUPPL-48	Manufacturing (CMC)		Label is not available on this site.
05/20/1988	SUPPL-44	Manufacturing (CMC)		Label is not available on this site.
03/03/1988	SUPPL-42	Manufacturing (CMC)		Label is not available on this site.
12/02/1986	SUPPL-40	Manufacturing (CMC)		Label is not available on this site.
07/26/1984	SUPPL-39	Manufacturing (CMC)		Label is not available on this site.
09/14/1983	SUPPL-38	Manufacturing (CMC)		Label is not available on this site.
05/26/1983	SUPPL-37	Manufacturing (CMC)		Label is not available on this site.
05/26/1983	SUPPL-36	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 085692

TRIAMCINOLONE ACETONIDE

CREAM;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%	CREAM;TOPICAL	Prescription	No	AT	207651	ALKEM LABS LTD
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.025%	CREAM;TOPICAL	Prescription	No	AT	208763	CHARTWELL RX
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.025%	CREAM;TOPICAL	Prescription	No	AT	089797	COSETTE PHARMS NC
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.025%	CREAM;TOPICAL	Prescription	Yes	AT	085692	FOUGERA PHARMS
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.025%	CREAM;TOPICAL	Prescription	No	AT	209535	MACLEODS PHARMS LTD
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.025%	CREAM;TOPICAL	Prescription	No	AT	040671	MICRO LABS
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.025%	CREAM;TOPICAL	Prescription	No	AT	086413	PADAGIS US
TRIDERM	TRIAMCINOLONE ACETONIDE	0.025%	CREAM;TOPICAL	Prescription	No	AT	088042	CROWN LABS

CREAM;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%	CREAM;TOPICAL	Prescription	No	AT	207651	ALKEM LABS LTD
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.5%	CREAM;TOPICAL	Prescription	No	AT	208763	CHARTWELL RX
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.5%	CREAM;TOPICAL	Prescription	Yes	AT	085692	FOUGERA PHARMS
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.5%	CREAM;TOPICAL	Prescription	No	AT	209535	MACLEODS PHARMS LTD
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.5%	CREAM;TOPICAL	Prescription	No	AT	086413	PADAGIS US
TRIDERM	TRIAMCINOLONE ACETONIDE	0.5%	CREAM;TOPICAL	Prescription	No	AT	088042	CROWN LABS

CREAM;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%	CREAM;TOPICAL	Prescription	No	AT	207651	ALKEM LABS LTD
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.1%	CREAM;TOPICAL	Prescription	No	AT	208763	CHARTWELL RX
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.1%	CREAM;TOPICAL	Prescription	No	AT	089798	COSETTE PHARMS NC
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.1%	CREAM;TOPICAL	Prescription	No	AT	208848	ENCUBE
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.1%	CREAM;TOPICAL	Prescription	Yes	AT	085692	FOUGERA PHARMS
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.1%	CREAM;TOPICAL	Prescription	No	AT	209535	MACLEODS PHARMS LTD
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.1%	CREAM;TOPICAL	Prescription	No	AT	040671	MICRO LABS
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.1%	CREAM;TOPICAL	Prescription	No	AT	086413	PADAGIS US
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.1%	CREAM;TOPICAL	Prescription	No	AT	040039	TARO
TRIDERM	TRIAMCINOLONE ACETONIDE	0.1%	CREAM;TOPICAL	Prescription	No	AT	088042	CROWN LABS

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