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Last Updated: November 27, 2024

Details for New Drug Application (NDA): 212411


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NDA 212411 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 212411
Tradename:POSACONAZOLE
Applicant:Sinotherapeutics Inc
Ingredient:posaconazole
Patents:0
Pharmacology for NDA: 212411
Suppliers and Packaging for NDA: 212411
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
POSACONAZOLE posaconazole TABLET, DELAYED RELEASE;ORAL 212411 ANDA Lannett Company Inc. 0527-2133 0527-2133-30 24 TABLET, DELAYED RELEASE in 1 CARTON (0527-2133-30)
POSACONAZOLE posaconazole TABLET, DELAYED RELEASE;ORAL 212411 ANDA Lannett Company Inc. 0527-2133 0527-2133-35 60 TABLET, DELAYED RELEASE in 1 BOTTLE (0527-2133-35)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength100MG
Approval Date:Aug 21, 2019TE:ABRLD:No

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