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Last Updated: November 24, 2024

Details for New Drug Application (NDA): 204439

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NDA 204439 describes TIGECYCLINE, which is a drug marketed by Accord Hlthcare Inc, Amneal, Apotex, Eugia Pharma, Fresenius Kabi Usa, Meitheal, Sandoz, and Xellia Pharms Aps, and is included in eight NDAs. It is available from six suppliers. There is one patent protecting this drug. Additional details are available on the TIGECYCLINE profile page.

The generic ingredient in TIGECYCLINE is tigecycline. There are ten drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the tigecycline profile page.

Summary for 204439

Tradename:	TIGECYCLINE
Applicant:	Apotex
Ingredient:	tigecycline
Patents:	0

Pharmacology for NDA: 204439

Suppliers and Packaging for NDA: 204439

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TIGECYCLINE	tigecycline	POWDER;INTRAVENOUS	204439	ANDA	Apotex Corp	60505-6098	60505-6098-1	10 VIAL, SINGLE-USE in 1 CARTON (60505-6098-1) / 5 mL in 1 VIAL, SINGLE-USE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAVENOUS			Strength	50MG/VIAL
Approval Date:	Dec 21, 2018	TE:	AP	RLD:	No

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