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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 219057
Company: ASPIRO

Products on ANDA 219057

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
POSACONAZOLE	POSACONAZOLE	300MG/16.7ML (18MG/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 219057

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/23/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 219057

POSACONAZOLE

SOLUTION;INTRAVENOUS; 300MG/16.7ML (18MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
POSACONAZOLE	POSACONAZOLE	300MG/16.7ML (18MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	219057	ASPIRO
POSACONAZOLE	POSACONAZOLE	300MG/16.7ML (18MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	214842	EUGIA PHARMA
POSACONAZOLE	POSACONAZOLE	300MG/16.7ML (18MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	209983	FRESENIUS KABI USA
POSACONAZOLE	POSACONAZOLE	300MG/16.7ML (18MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	217553	GLAND
POSACONAZOLE	POSACONAZOLE	300MG/16.7ML (18MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	211500	MYLAN LABS LTD
POSACONAZOLE	POSACONAZOLE	300MG/16.7ML (18MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	208768	PH HEALTH

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