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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 209983

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NDA 209983 describes POSACONAZOLE, which is a drug marketed by Aspiro, Eugia Pharma, Fresenius Kabi Usa, Gland, Mylan Labs Ltd, Ph Health, Hikma, Actavis Labs Fl Inc, Aet Pharma, Amneal, Aurobindo Pharma, Biocon Pharma, Dr Reddys, Hetero Labs Ltd Iii, I 3 Pharms, MSN, Qilu Pharm Hainan, Sinotherapeutics Inc, Specgx Llc, and Westminster Pharms, and is included in twenty NDAs. It is available from twenty-eight suppliers. Additional details are available on the POSACONAZOLE profile page.

The generic ingredient in POSACONAZOLE is posaconazole. There are twenty-one drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the posaconazole profile page.

Summary for 209983

Tradename:	POSACONAZOLE
Applicant:	Fresenius Kabi Usa
Ingredient:	posaconazole
Patents:	0

Pharmacology for NDA: 209983

Suppliers and Packaging for NDA: 209983

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
POSACONAZOLE	posaconazole	SOLUTION;INTRAVENOUS	209983	ANDA	Fresensius Kabi USA, LLC	63323-685	63323-685-17	1 VIAL, SINGLE-DOSE in 1 CARTON (63323-685-17) / 16.7 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	300MG/16.7ML (18MG/ML)
Approval Date:	Dec 26, 2023	TE:	AP	RLD:	No

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