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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 214476


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NDA 214476 describes POSACONAZOLE, which is a drug marketed by Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Mylan Labs Ltd, Par Sterile Products, Hikma, Actavis Labs Fl Inc, Aet Pharma, Amneal, Biocon Pharma, Dr Reddys, Hetero Labs Ltd Iii, I 3 Pharms, Sinotherapeutics Inc, Specgx Llc, and Westminster Pharms, and is included in sixteen NDAs. It is available from twenty-five 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-seven suppliers are listed for this compound. Additional details are available on the posaconazole profile page.
Summary for 214476
Tradename:POSACONAZOLE
Applicant:Biocon Pharma
Ingredient:posaconazole
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 214476
Suppliers and Packaging for NDA: 214476
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
POSACONAZOLE posaconazole TABLET, DELAYED RELEASE;ORAL 214476 ANDA Biocon Phama Inc. 70377-038 70377-038-11 60 TABLET, DELAYED RELEASE in 1 BOTTLE (70377-038-11)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength100MG
Approval Date:Feb 4, 2022TE:ABRLD:No

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