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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 207355

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NDA 207355 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 207355

Tradename:	POSACONAZOLE
Applicant:	Actavis Labs Fl Inc
Ingredient:	posaconazole
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	100MG
Approval Date:	Nov 30, 2022	TE:		RLD:	No

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