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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 205645

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NDA 205645 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 205645

Tradename:	TIGECYCLINE
Applicant:	Fresenius Kabi Usa
Ingredient:	tigecycline
Patents:	0

Pharmacology for NDA: 205645

Suppliers and Packaging for NDA: 205645

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TIGECYCLINE	tigecycline	POWDER;INTRAVENOUS	205645	NDA	Fresenius Kabi USA, LLC	63323-960	63323-960-10	10 VIAL, SINGLE-DOSE in 1 CARTON (63323-960-10) / 5 mL in 1 VIAL, SINGLE-DOSE (63323-960-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAVENOUS			Strength	50MG/VIAL
Approval Date:	Dec 1, 2016	TE:	AP	RLD:	Yes

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