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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040037
Company: SUN PHARMA CANADA

Products on ANDA 040037

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040037

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/30/1994	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
10/26/2016	SUPPL-16	Labeling-Container/Carton Labels		Label is not available on this site.
06/30/1998	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
11/28/1997	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
11/28/1997	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
11/28/1997	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
09/17/1996	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
12/15/1995	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 040037

TRIAMCINOLONE ACETONIDE

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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