Details for New Drug Application (NDA): 213106

NDA 213106 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 213106

Tradename:	FOSAPREPITANT DIMEGLUMINE
Applicant:	Qilu Pharm Hainan
Ingredient:	fosaprepitant dimeglumine
Patents:	0

Pharmacology for NDA: 213106

Mechanism of Action

Cytochrome P450 2C9 Inducers Cytochrome P450 3A4 Inducers Cytochrome P450 3A4 Inhibitors Neurokinin 1 Antagonists

Suppliers and Packaging for NDA: 213106

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FOSAPREPITANT DIMEGLUMINE	fosaprepitant dimeglumine	POWDER;INTRAVENOUS	213106	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9384	0143-9384-01	1 VIAL, SINGLE-DOSE in 1 CARTON (0143-9384-01) / 5 mL in 1 VIAL, SINGLE-DOSE
FOSAPREPITANT DIMEGLUMINE	fosaprepitant dimeglumine	POWDER;INTRAVENOUS	213106	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9428	0143-9428-01	1 VIAL, SINGLE-DOSE in 1 CARTON (0143-9428-01) / 5 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAVENOUS			Strength	EQ 150MG BASE/VIAL
Approval Date:	Sep 8, 2020	TE:	AP	RLD:	No

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