Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215840
Company: EUGIA PHARMA SPECLTS

Products on ANDA 215840

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ETELCALCETIDE	ETELCALCETIDE	2.5MG/0.5ML	INJECTABLE;INJECTION	None (Tentative Approval)	None	No	No
ETELCALCETIDE	ETELCALCETIDE	5MG/ML	INJECTABLE;INJECTION	None (Tentative Approval)	None	No	No
ETELCALCETIDE	ETELCALCETIDE	10MG/2ML	INJECTABLE;INJECTION	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 215840

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/08/2023	ORIG-1	Tentative Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/215840Orig1s000TA_ltr.pdf