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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 210625


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NDA 210625 describes FOSAPREPITANT DIMEGLUMINE, which is a drug marketed by Accord Hlthcare, Apotex, Arthur Grp, Aspiro, Baxter Hlthcare Corp, Be Pharms, Chia Tai Tianqing, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Geneyork Pharms, Lupin Ltd, MSN, Mylan Labs Ltd, Navinta Llc, Piramal Critical, Qilu Pharm Hainan, Sandoz, and Teva Pharms Usa, and is included in nineteen NDAs. It is available from nineteen suppliers. Additional details are available on the FOSAPREPITANT DIMEGLUMINE profile page.

The generic ingredient in FOSAPREPITANT DIMEGLUMINE is fosaprepitant dimeglumine. There are eleven drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the fosaprepitant dimeglumine profile page.
Summary for 210625
Tradename:FOSAPREPITANT DIMEGLUMINE
Applicant:Eugia Pharma
Ingredient:fosaprepitant dimeglumine
Patents:0
Suppliers and Packaging for NDA: 210625
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FOSAPREPITANT DIMEGLUMINE fosaprepitant dimeglumine POWDER;INTRAVENOUS 210625 ANDA Eugia US LLC 55150-299 55150-299-01 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-299-01) / 5 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrengthEQ 150MG BASE/VIAL
Approval Date:Jan 12, 2021TE:APRLD:No

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