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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 209983


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NDA 209983 describes POSACONAZOLE, which is a drug marketed by Endo Operations, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Mylan Labs Ltd, Hikma, Actavis Labs Fl Inc, Aet Pharma, Amneal, Aurobindo Pharma, Biocon Pharma, Dr Reddys, Hetero Labs Ltd Iii, I 3 Pharms, Sinotherapeutics Inc, Specgx Llc, and Westminster Pharms, and is included in seventeen NDAs. It is available from twenty-seven 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-eight 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:RXDosage:SOLUTION;INTRAVENOUSStrength300MG/16.7ML (18MG/ML)
Approval Date:Dec 26, 2023TE:APRLD:No

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