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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 086413
Company: PADAGIS US

Products on ANDA 086413

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 086413

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/09/1981	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
01/25/2002	SUPPL-14	Manufacturing (CMC)-Packaging		Label is not available on this site.
12/10/1996	SUPPL-13	Labeling		Label is not available on this site.
01/25/1993	SUPPL-12	Labeling		Label is not available on this site.
06/08/1992	SUPPL-11	Labeling		Label is not available on this site.
06/09/1986	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
07/11/1984	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
04/28/1986	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
06/16/1982	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 086413

TRIAMCINOLONE ACETONIDE

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
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.5%	CREAM;TOPICAL	Prescription	No	AT	210346	STRIDES PHARMA
TRIDERM	TRIAMCINOLONE ACETONIDE	0.5%	CREAM;TOPICAL	Prescription	No	AT	088042	CROWN LABS

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
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
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.025%	CREAM;TOPICAL	Prescription	No	AT	210346	STRIDES PHARMA
TRIDERM	TRIAMCINOLONE ACETONIDE	0.025%	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
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	207117	GLENMARK PHARMS LTD
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	210346	STRIDES PHARMA
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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