Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207550
Company: AMNEAL

Products on ANDA 207550

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE;INJECTION	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 207550

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/11/2017	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207550Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/03/2019	SUPPL-3	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 207550

TRIAMCINOLONE ACETONIDE

INJECTABLE;INJECTION; 40MG/ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
KENALOG-40	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AB	014901	APOTHECON
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE;INJECTION	Prescription	No	AB	207550	AMNEAL
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE;INJECTION	Prescription	No	AB	212400	EUGIA PHARMA
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE;INJECTION	Prescription	No	AB	213543	LONG GROVE PHARMS
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE;INJECTION	Prescription	No	AB	212567	MYLAN LABS LTD
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	40MG/ML	INJECTABLE;INJECTION	Prescription	No	AB	209852	TEVA PHARMS USA