An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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
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 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; 0.1%
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

Top