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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 208773

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NDA 208773 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 208773

Tradename:	POSACONAZOLE
Applicant:	Hikma
Ingredient:	posaconazole
Patents:	0

Pharmacology for NDA: 208773

Suppliers and Packaging for NDA: 208773

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
POSACONAZOLE	posaconazole	SUSPENSION;ORAL	208773	ANDA	Hikma Pharmaceuticals USA Inc.	0054-0449	0054-0449-49	1 BOTTLE, GLASS in 1 CARTON (0054-0449-49) / 105 mL in 1 BOTTLE, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION;ORAL			Strength	40MG/ML
Approval Date:	May 15, 2020	TE:	AB	RLD:	No

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