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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 087385
Company: PADAGIS US

Products on ANDA 087385

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 087385

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/05/1981	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
03/26/1999	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
06/14/1995	SUPPL-13	Labeling		Label is not available on this site.
05/13/1988	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
09/23/1986	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
06/09/1986	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
07/11/1984	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
04/28/1986	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 087385

TRIAMCINOLONE ACETONIDE

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	206379	GLENMARK PHARMS LTD
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; 0.025%
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; 0.1%
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	208320	GLENMARK 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	TARO

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