Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212384
Company: ENCUBE

Products on ANDA 212384

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT;TOPICAL	Prescription	AT	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 212384

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/29/2019	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/212384Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 212384

TRIAMCINOLONE ACETONIDE

OINTMENT;TOPICAL; 0.05%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT;TOPICAL	Prescription	No	AT	214532	CHARTWELL RX
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT;TOPICAL	Prescription	No	AT	213619	CINTEX SVCS
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT;TOPICAL	Prescription	No	AT	212384	ENCUBE
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT;TOPICAL	Prescription	No	AT	216625	MACLEODS PHARMS LTD
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT;TOPICAL	Prescription	No	AT	212460	PADAGIS ISRAEL
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT;TOPICAL	Prescription	No	AT	212356	STRIDES PHARMA