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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216625
Company: MACLEODS PHARMS LTD

Products on ANDA 216625

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	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216625

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/18/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 216625

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	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	213619	SENORES PHARMS
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.05%	OINTMENT;TOPICAL	Prescription	No	AT	212356	STRIDES PHARMA

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