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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 212226


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NDA 212226 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 212226
Tradename:POSACONAZOLE
Applicant:Specgx Llc
Ingredient:posaconazole
Patents:0
Pharmacology for NDA: 212226
Suppliers and Packaging for NDA: 212226
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
POSACONAZOLE posaconazole TABLET, DELAYED RELEASE;ORAL 212226 ANDA SpecGx LLC 0406-7711 0406-7711-60 60 TABLET, DELAYED RELEASE in 1 BOTTLE (0406-7711-60)
POSACONAZOLE posaconazole TABLET, DELAYED RELEASE;ORAL 212226 ANDA Golden State Medical Supply, Inc. 51407-676 51407-676-60 60 TABLET, DELAYED RELEASE in 1 BOTTLE (51407-676-60)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength100MG
Approval Date:May 10, 2022TE:ABRLD:No

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